`
`D AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION'AND RESEARCH
`OFFICE OF MANAGEMENT
`JANUARY 1996
`
`w—OFFICIA‘L USE ONLY—j
`
`
`
`
`
`InnoPharma Exhibit 1080.0001
`
`

`

`
`
`n approved drug products or conditionaiiy
`ide contains ail inactive ingredients present i
`The Guide is compiied by the Division of Drug information
`ctive ingredients in products which have been
`Purpose The Inactive Ingredient Gu
`arketed for human use.
`d drug product for a particuiar route of
`R/CBER Revrewers with information on ina
`approved drug pro
`tive ingredient appears in a currentiy approve
`Resources fDDiR).
`it provides CDE
`iess extensive review
`uid not usuaiiy be considered new and may require a
`approved by the Agency Once an inac
`by route of administration
`administration, the inactive ingredient we
`iiy by ingredient, and then
`iphabetica
`ent approved iabeiing.
`8 has been sorted first a
`derived from curr
`ctive ingredient Guidtration and dosage forms are
`Design The I‘na
`f adminis
`and dosage form. Routes 0
`ngredients and active ingredients a
`defines inactive i
`redient means any compo
`21 CFR 210.3ibii8,7, respectiveiyi
`tive ingredient. Active ing
`Definitions
`gicai activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prev
`ingredient means any component other than the ac
`an or animais. The term iactive ingredient) inciudes those
`in the finished drug
`and be present
`to furnish pharmacoio
`ture or any function of the body of m
`ture of the drug product
`ption of the CFR definition, inactive
`dergo chemical change in the manufac
`or to affect the struc
`ity or effect." As an exce
`product.
`ed to furnish the specified activ
`t in the finai dosage form of the drug
`components that may on
`product in a modified form intend
`'4
`iy those which are presen
`Since many ingredients have
`ingredients iisted in the Guide inciude on
`it ingredients contained in submissions to CDER.
`you to contact your Drug information Officer
`DDiR maintains a dictionary of a
`edient Guide), it may assist
`the Inactive Ingr
`synonyms (w
`‘
`
`“inactive
`s foiiows:
`nent that is intended
`ention of disease,
`
`
`
`‘ .\
`
`Synonyms
`
`etary inactive ingredients ie.g.,
`nts of propri
`you may have to search
`iude the compone
`dients are included,
`DDiR does not aiways inc
`ve ingre
`onents of proprietary inacti
`Proprietary inactive
`ch situations where comp
`OPACODES).
`in so
`component entries.
`nded as such by the manufa
`for such data under individuai
`o be considered as active ingredients under different circumstances (see 21 CFR
`Warnings The Inactive Ingredient Guide iists inactive ingredients specificaiiy inte
`e ingredients which physicaiiy or chemicaiiy
`fthis Guide.
`1 kits, or inactiv
`of these inactive ingredients could ais
`sidered 'as inactive ingredients for the purposes 0
`210.3(b)(7,3i)t Furthermore, reactants in
`combine with active ingredients to faciiitate
`
`if you cannot
`
`cturer. Some
`
`radiopharmaceutica
`drug transport are con
`
`iContinuedi
`
`E
`
`
`
`
`
`InnoPharma Exhibit 1080.0002
`
`

`

`
`
`Contaminants The inactive ingredient Guide does not represent contaminants found in approved drug products,
`
`if any of the inactive ingredients represented in the Inactive /ngredient Guide are proven to be
`Carcinogens and Teratogens
`carcinogenic, teratogenic, or embryotoxic, please notify DDlR immediately, DDiR will attempt to relay your concern to each
`medicai officer and pharmacologist reviewer responsible for oversight of other approved drug products which contain the
`specified inactive ingredient.
`
`CAS Number Many inactive ingredients have Chemical Abstracts Service lCAai numbers associated with them. These can
`be found in the column to the right of the inactive ingredient. CAS numbers maybe helpful to CDER/CBER Reviewers when
`initiating computer-assisted searches with the National Library of Medicine's :pniine data bases.
`
`Qualitative NDA Data The next five columns to the right of the CAS numberjsetve to qualify the data presented. The NBA
`
`CT' reflects the total number of NDAs in which a particular inactive ingredien
`"Wrently appears. The ’Last NDA’ specifies
`which NDA was the most recent one to be approved by the Agency with thisinactrve ingredient. The ’APPROVAL DATE' and
`’DIV' specify the approvai date and Review Division responsible for evaluating this most recent NBA. The ’POTENCY RANGE'
`specifies the minimum and maximum amounts of inactive ingredients for each route of administration and dosage form.
`in
`some cases, values in the 'POTENCY RANGE' column have been collapsed into percentage of the total product in order to
`integrate data.
`
`
`
`Colors The Certification Branch of the Division of Color Technology has designated permanently listed, provisionally listed,
`and delisted color additives. These appear in the Appendix, Please consult the 21 CFR 74 and 82 for detailed information on
`uses, restrictions, and tolerances of color additives.
`.,
`
`inactive ingredient Structures Chemical structures of all inactive ingredients which have been submitted to the Agency are
`available for review by contacting Rona Sun or Kyung Kim, DDIR Chemists, at 443-3910.
`
`The DiviSion of Drug information Resources can also provide you with more
`Procedure for Obtaining Further Assistance
`specialized searches on the automated data base from which the Inactive ingredient Guide is generated. For assistance in using
`the Guide, to schedule a presentation on the Guide, or for a more detailed search, contact your DDIR Drug information Officer
`on the following page or Mark Askine at 443—0500.
`
`InnoPharma Exhibit 1080.0003
`
`

`

`
`
`DIVISION OF DRUG iNFORMATION RESOURCES
`
`DRUG INFORMATION OFFICERS
`
`Division of Cardio-Renai Drug Products, HFD~1 i0 ............................ Diane Centeno—Deshieids, RPh.
`
`Division of Neuropharmacoiogicai Drug Products, HFD~120 ..................... Diane Centeno-Deshieids, RPh.
`
`Division of Oncologic Drug Products, RFD-150 ,
`
`.
`
`i
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`, ............................ Sharon BrowneweiI
`
`Division of Medicai Imaging, Surgicai, and Dentai Products, HFD-iSO ...... '. .............. Herbert Thornton, RPh,
`Division of Anesthesic, Criticai Care, and Addiction Drug Products, HFD-i70 .................... Mary Guiiderson
`
`‘
`
`Division of Gastrointestinai and Coaguiation Drug Products, HFD—i 8O ....................... Richard Lioov, RPh
`
`Division of Metabolism and Endocrine Drug Products, HFD-SiO ........................... Ronaid Brown, RPh,
`'a
`
`' Division of Anti—infective Drug Products, HFD—SZO ,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,, Mark W. Askine, RPh.
`
`Division of Antivirai Drug Products, HFD‘SBO ........................................ Lee Anne Parsons
`
`Division of Dermatologic and Ophthaimoiogic Drug Products, HFD~54O
`
`................... Mark W. Askine, RiPh
`
`Division of Anti-inflammatory, Anaigesic, and Dentai Drug Products, HFD-SSO ................... Mary Guilderson
`
`Division of Puimonarv Drug Products, RFD-570 ...................................... Sharon Browneweii
`
`
`
`Division of Generic Drugs, HFD-BOO .......................... ,................... Janet Anderson, RPh,
`
`Ail DDIR Drug Information Officers can be contacted at 443-0500 and are iocated in Room 218 of the Chapman Building.
`
`InnoPharma Exhibit 1080.0004
`
`

`

`
`
`iNACTiVE iNGREDIENT FIELD DESCRIPTION
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`ACACIA
`
`CAS#
`
`009000015
`
`BUCCALISUBLINGUAL; TABLET
`ORAL; CAPSULE
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; POWDER
`
`ingredient Chemicai substance added to enhance formulation oi given
`dosage forms. Component of product other than active ingredient.
`
`Route/Dosage Form Formuiation intended for the specified route of
`administration or site of application.
`
`GAS/9‘ Registry number assigned to a compound by Chemicai Abstracts
`Service on a random basis.
`
`NDA
`COUNT
`
`LAST
`NDA
`N85125
`NBSZSS
`“17078
`N16640
`
`APPROVAL
`DATE
`02/02/77
`04/01/77
`08/02/76
`08/03/73
`
`DiViSiON
`600
`600
`120
`510
`
`FOTENCY
`RANGE
`4.0 a 9,1 MG
`
`0.01- 0.7 MG
`21.0%
`
`NDA Count Reflects total number of approved NDAs in which a parth
`particuiar inactive ingredient currentiy appears.
`
`Last NDA Specifies which NDA was the most recent one to be
`approved by the Agency with this active ingredient.
`
`Approvai Date and DIV Specifies the approvai date and the Review
`Division responsibie for evaioating this most recent NDA.
`
`Specifies the minimum and maximum amounts of
`Potency Range
`inactive ingredients for each route/dosage form.
`
`InnoPharma Exhibit 1080.0005
`
`

`

`
`
`
`
`E
`
`.
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`CAS 3
`NBA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV
`
`POTENCY RANGE
`
`ACACIA
`BUCCAL/SUBLINGUAL; TABLET
`ORAL; CAPSULE
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; POWDER
`ORAL; POWDER, FOR RECONSTITUTION
`ORAL: SYRUP
`ORAL; TABLET
`ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED,
`ORAL; TABLET, COATED
`ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
`ORAL; TABLET, FILM COATED
`ORAL; TABLET, REPEAT ACTION
`ORAL; TABLET, SUSTAINED ACTION
`ORAL-21; TABLET
`ORAL-28; TABLET
`ACACIA MUCILAGE
`ORAL; TABLET, COATED
`ACETIC ACID
`INJECTION
`IN - IV - SC;
`IM - SC;
`INJECTION
`INTRAMUSCULAR;
`INJECTION
`INTRAVENOUS;
`INJECTION
`IV(INFUSION);
`INJECTION
`OPHTHALMIC; POWDER, FOR RECONSTITUTION
`OPHTHALMIC; SOLUTION
`SUBCUTANEOUS;
`INJECTION
`TOPICAL; SOLUTION
`TOPICAL; SPONGE
`ACETIC ACID, GLACIAL
`IM - IV - SC; POWDER, FOR INJECTION SOLUTION
`IM - IV;
`INJECTION
`IN - IV; PONDER, FOR INJECTION SOLUTION
`IN - SC;
`INJECTION
`M - SC;
`INJECTION, SUSTAINED ACTION
`NTRA-ARTICULAR;
`INJECTION
`INTRAMUSCULAR;
`INJECTION
`INTRASYNOVIAL;
`INJECTION
`INTRAVENOUS;
`INJECTION
`IRRIGATION; SOLUTION
`IV(INFUSION);
`INJECTION
`IV(INFUSION); POWDER, FOR INJECTION SOLUTION
`IV(INFUSION); SOLUTION,
`INJECTION
`NASAL; SOLUTION
`NASAL; SPRAY, METERED
`OPHTHALMIC; SOLUTION
`ORAL; CAPSULE, HARD GELATIN
`
`,
`
`1
`‘
`
`7”
`
`009000015
`
`008047389
`
`000064197
`
`PAGE 1
`
`
`
`MmwhnflwhndflfiduohbufldflrdmhdWhudwwnooondwHbhHNN\UdHKHNHhD-Hh~w
`
`NH
`
`03/08/88
`
`snn
`
`09/29/95
`07/29/92
`02/25/92
`
`03/15/86
`03/31/81
`01/04/95
`10/01/76
`03/29/76
`
`600
`600
`600
`
`600
`UNK
`600
`510
`510
`
`0.03GH
`3.22MG ~ 80.0MG
`0.02MB - 156.0MG
`
`0.04MB - 0.08MG
`11.542HG
`2.0MG - 34.4MG
`1.26MB
`1.26MB
`
`07/09/80
`07/31/90
`03/25/94
`
`510
`600
`160
`
`0.0462
`0.0272 — 0.442
`
`05/02/88
`
`00/14/95
`
`Ob/OIIIU
`05/02/88
`05/07/78
`03/17/94
`
`600
`
`600
`
`600
`600
`600
`UNK
`
`0.135% - OTZSX
`
`0.012 ‘ 0.48%
`
`0.006% ~ 0.04422
`
`0.01% - 0.225%
`
`IU/ZI/95
`
`510
`
`0.122 - 0.435%
`
`InnoPharma Exhibit 1080.0006
`
`
`
`
`
`

`

`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`ACETIC ACID, GLACIAL
`ORAL; CONCENTRATE
`ORAL: SOLUTION, ELIXIR
`OTIC; SOLUTION
`OTIC; SUSPENSION
`SUBCUTANEOUS;
`INJECTION
`ACETIC ANHYDRIOE
`ORAL; TABLET, SUSTAINED ACTION
`ACETONE SODIUM BISULFITE
`DENTAL;
`INJECTION
`INHALATION; SOLUTION
`NERVE BLOCK}
`INJECTION
`ACETYL TRIBUTYL CITRATE
`ORAL; CAPSULE, ENTERIC COATED PELLETS
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; TABLET, ENTERIC COATED PARTICLES
`ORAL; TABLET, SUSTAINED ACTION
`ACETYLATED MONOGLYCERIOES
`INTRAVENOUS;
`INJECTION
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; TABLET
`ORAL; TABLET, COATED
`ORAL} TABLET, DELAYED ACTION, ENTERIC COATED
`ORAL; TABLET, FILM COATED
`ORAL; TABLET, SUSTAINED ACTION
`ACETYLCYSTEINE
`INHALATION; SOLUTION
`.ACRYLATES COPOLYMER
`TRANSDERMAL; FILM, CONTROLLED RELEASE
`ADCOTE 72A103
`TRANSDERMAL; FILM, CONTROLLED RELEASE
`AEROSIL 380
`ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
`AEROSIL-ZOO
`ORAL: TABLET
`ORAL; TABLET, FILM COATED
`3
`AEROTEX RESIN 3730
`R TRANSDERMAL; FILM, CONTROLLED RELEASE
`1NHALATION;'6AS
`ALBUMIN AGGREGATED
`.
`INTRAVENOUS;
`INJECTION
`ALBUMIN COLLOIDAL
`INTRAVENOUS; POWDER, FOR INJECTION SOLUTION
`
`AI
`
`CAS #
`
`000064197
`
`000108247
`
`000540921
`
`000616911
`
`NBA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV
`
`POTENCY RANGE
`
`12/16/85
`
`600
`
`0.075% - 0.1%
`
`11/06/85
`06/12/91
`
`600
`510
`
`.362
`
`DC
`
`06/30/81
`11/15/79
`
`£60
`500
`
`COG~
`
`W-‘MNN
`
`II
`
`012')
`
`NU‘I NO
`
`01/10/92
`
`110
`
`2.0MG ~ 9,0MG
`
`04/21/91
`04/26/78
`03/29/82
`02/02/87
`05/14/85
`
`11/22/88
`
`600
`600
`600
`600
`UNK
`
`600
`
`0.04MB - 2.7MG
`
`.92MG - 5.17MB
`.OQMG - 2.1MG
`
`5N
`
`08/17/88
`02/02/87
`
`600
`600
`
`0.1MG — 9.0MG
`3.6MG - 7.2MG
`
`1'
`
`10/01/82
`
`12/30/87
`
`160
`
`160
`
`0.025%
`
`
`
`paN(N*WU!OJWNOP“HWDWONNWHHNNNHDIN!“HNNHHN.
`
`III
`
`.
`
`PAGE 2
`
`E
`%
`,
`
`
`
`
`
`
`InnoPharma Exhibit 1080.0007
`
`

`

`
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`INJECTION
`
`ALBUNIN HUMAN
`INJECTION
`INTRAVENOUS;
`INTRAVENOUS; POWDER, FOR INJECTION SOLUTION
`IV(INFUSION);
`INJECTION
`ALCOHOL
`DENTAL; SOLUTION
`IM - IV;
`INJECTION
`INJECTION
`1M - IV; SOLUTION,
`INHALATION; AEROSOL, METEREO
`INHALATION; SOLUTION
`INTRAMUSCULAR;
`INJECTION
`INTRAVENOUS;
`INJECTION
`IV - SC;
`INJECTION
`IV(INFUSION);
`INJECTION
`IV(INFUSION); SOLUTION,
`OPNTHALMIC; SOLUTION
`ORAL; AEROSOL SPRAY
`ORAL; CONCENTRATE
`ORAL; SOLUTION
`ORAL; SOLUTION, ELIXIRV
`ORAL; SUSPENSION
`ORAL; SYRUP
`RECTAL; SUSPENSION
`TOPICAL; AEROSOL SPRAY
`TOPICAL; GEL
`TOPICAL; LOTION
`TOPICAL; SOLUTION
`TRANSOERMAL; FILM, CONTROLLED RELEASE
`VAGINAL; EMULSION, CREAM
`ALCOHOL, OENYDRATED
`IH - IV;
`INJECTION
`IM - IV; POHDER, FOR INJECTION SOLUTION
`INHALATION; AEROSOL, METERED
`INTRAMUSCULAR;
`INJECTION
`INTRAVASCULAR;
`INJECTION
`INTRAVENOUS;
`INJECTION
`IV(INFUSIONJ;
`INJECTION
`IV(INFUSION); PONDER, FOR INJECTION SOLUTION
`IV(INFUSION); SOLUTION,
`INJECTION
`NASAL; AEROSOL SPRAY
`NASAL; AEROSOL, METERED
`OPHTHALMIC; SOLUTION
`ORAL; CONCENTRATE
`ORAL; SOLUTION
`ORAL; SOLUTION, ELIXIR
`ORAL; SUSPENSION
`ORAL; SYRUP
`
`.
`
`
`
`
`
`
`
`CAS :
`
`009006535
`
`000064175
`
`000064175
`
`,
`
`PAGE 3
`
`NDA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV
`
`POTENCY RANGE
`
`kuvm>amhuamwnabHFJQ
`
`HOCOQU‘mNh-‘HHHNUNHN-bwfi“NWNNH
`
`y.»
`
`12/28/90
`
`510
`
`0.05% - 1.2%
`
`12/28/95
`01/29/93
`
`600
`600
`
`10.02 - 12.152
`8.55% - 11402
`
`12/28/69
`
`UHK
`
`au.un - 38.02
`
`02/10/94
`
`08/50/95
`12/31/86
`
`08/30/91
`11/17/95
`04/29/93
`09/15/95
`10/28/94
`11/17/86
`
`06/13/90
`07/03/85
`02/27/95
`09/29/95
`
`10/13/87
`
`09/25/52
`11/30/89
`
`07/11/95
`08/30/95
`
`10/11/88
`11/30/94
`07/14/95
`01/25/82
`06/18/87
`11/22/85
`
`600
`
`600
`110
`
`600
`530
`600
`180
`600
`800
`
`UNK
`600
`600
`510
`
`600
`
`UHK
`UNK
`
`600
`600
`
`600
`600
`530
`600
`600
`600
`
`6182 - 30.5%
`
`0.612 - 62.92
`10.0% ~ 30.02
`
`.019Z - 71.6%
`.232 - 30.02
`.02 - 20.4%
`.00000672 ~ 7.252
`.52 ' 7.5K
`
`DDU‘DC’
`
`52.02
`71.02 ~ 80.52
`33.0% - 83.0%
`
`0.012 ~ 10.02
`
`1.02 - 34.5482
`10,02
`
`5.0% ~ 50.0%
`10.02 - 80.02
`
`0.52
`0.000032 - 7.37%
`0.12 - 24.9%
`12.0% - 20.02
`0.26% ’ 1.02
`5.02 - 7.0%
`
`InnoPharma Exhibit 1080.0008
`
`

`

`
`
`
`
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`ALCOHOL, DEHYDRATED
`TOPICAL; GEL
`TOPICAL; SOLUTION
`TOPICAL; SHAB
`ALCOHOL, DENATURED
`DENTAL} GEL
`DENTAL; PASTE
`TOPICAL; AEROSOL
`TOPICAL: EMULSION, AEROSOL FOAM
`TOPICAL; GEL
`TOPICAL; SOLUTION
`TOPICAL; SHAB
`ALCOHOL, DILUTED
`IM -
`IV;
`INJECTION
`ORAL; SOLUTION
`ORAL; SOLUTION, ELIXIR
`ORAL} SUSPENSION
`ORAL} SYRUP
`TOPICAL; AEROSOL SPRAY
`TOPICAL; POWDER, FOR RECONSTITUTION
`ALGINIC ACID
`OPHTHALMIC; DRUG DELIVERY SYSTEM
`OPHTHALMIC; SUPPOSITORY,
`INSERT, CONTROLLED RELEASE
`ORAL; CAPSULE
`ORAL; TABLET
`ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED,
`ORAL; TABLET, COATED
`ORAL; TABLET, FILM COATED
`ORAL; TABLET, SUSTAINED ACTION
`ALKYL AMMONIUM’SULFONIC ACID BETAINE
`TOPICAL} SPONGE
`ALKYL ARYL SODIUM SULFONATE
`TOPICAL; SUSPENSION, SHAMPOO
`ALLANTOIN
`TOPICAL; GEL
`VAGINAL; EMULSION, CREAM
`ALTHEA
`ORAL; SUSPENSION
`ALUMINUM ACETATE
`OTIC; SOLUTION
`TOPICAL; EMULSION, CREAM
`TOPICAL; SHAMPOO
`ALUMINUM NYDROXIDE
`TOPICAL; EMULSION, CREAM
`TOPICAL; OINTMENT
`
`,
`
`CAS 3
`
`000064175
`
`008024951
`
`008000166
`
`009005327
`
`000097596
`
`090139128.
`
`001302290
`
`PAGE 4
`
`”I
`
`NBA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`01/29/93
`92/29/90
`
`DIV
`
`600
`600
`
`POTENCY RANGE
`
`”Nu“
`
`20.0% - 94.78082
`55.0% - 77.0%
`
`
`
`
`
`h)»HHJHHFMHHwhufiwamruwpawwrauthNJHNlnounwnapHumn
`
`10/26/84
`01/11/91
`07/30/93
`
`UNK
`600
`600
`
`75.352 — 96.9385Z
`44.0z ~ 60.16%
`75.02
`
`05/16/79
`
`UE/ZI/IB
`
`600
`
`680
`
`6.81767
`
`0.52 ' 1.52
`
`05/14/86
`12/29/94
`06/28/39
`
`600
`110
`600
`
`17.0MG
`0.07MG - 30.0MG
`TSO_OMG - 400.0MG
`
`UVIUSIBO
`
`600
`
`16.800MG ~ 52.8MG
`
`12/22/87
`10/10/85
`
`600
`600
`
`5.0%
`
`InnoPharma Exhibit 1080.0009
`
`

`

`
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`
`
`
`
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`ALUMINUM HYDROXIDE - SUCROSE, HYDRATED
`TOPICAL; EMULSION, CREAM
`ALUMINUM HYDROXIDE GEL
`TOPICAL; EMULSION, CREAM
`ALUMINUM HYDROXIDE GEL F 500
`TOPICAL; EMULSION, CREAM
`ALUMINUM HYDROXIDE GEL F 5000
`TOPICAL; EMULSION, CREAM
`ALUMINUM HYDROXIDE GEL, DRIED
`ORAL; TABLET
`‘
`ALUMINUM OXIDE
`ORAL} TABLET
`ALUMINUM POLYESTER
`TRANSDERMAL} FILM, CONTROLLED RELEASE
`ALUMINUM POTASSIUM SULFATE
`VAGINAL; SUPPOSITORY
`ALUMINUM SILICATE
`ORAL; TABLET
`ORAL; TABLET, SUSTAINED ACTION
`TOPICAL; SUSPENSION, SHAMPOO
`ALUMINUM STARCH OCTENYLSUCCINATE
`TOPICAL; EMULSION, CREAM
`ALUMINUM STEARATE
`ORAL: TABLET
`ORAL; TABLET, SUSTAINEO ACTION
`TOPICAL; EMULSION, CREAM
`TOPICAL; OINTMENT
`ALUMINUM SULFATE
`OTIC; SOLUTION
`TOPICAL: EMULSION, CREAM
`ALZAMER-50
`ORAL; TABLET, SUSTAINED ACTION
`AMBERLITE
`ORAL} CAPSULE
`ORAL; TABLET
`ORAL; TABLET. COATED
`A ORAL; TABLET, FILM COATED
`AMERCHOL L101
`TOPICAL; EMULSION, CREAM
`AMERCHOL-CAB
`OPHTHALMIC; OINTMENT
`AMMONIA
`INHALATION; LIQUID
`AMMONIA SOLUTION
`ORAL; SUSPENSION
`
`CAS 5
`
`NBA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV
`
`POTENCY RANGE
`
`012040594
`
`008012633
`
`001344281
`
`012141467
`
`007047849
`
`010043013
`
`009002191
`
`008029047'
`
`007664417
`
`008007576
`
`PAGE 5
`
`wHNmHPMDHw(NMNuuuwwwrapHwwHNNaw
`
`01/29/93
`
`10/08/85
`
`10/08/85
`
`600
`
`600
`
`600
`
`0.3% - 1.0%
`
`2.02
`
`3.02
`
`10/29/93
`12/17/90
`
`02/25/94
`09/28/92
`
`UNK
`UNK
`
`600
`600
`
`12/21/90
`
`600
`
`1.0MG - 12.0MG
`
`08/25/89
`
`12/03/86
`
`UNK
`
`600
`
`1.02 - 5.0%
`
`InnoPharma Exhibit 1080.0010
`
`

`

`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`'
`
`'
`
`A
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`AMMONIUM ACETATE
`INJECTION
`INTRANUSCULAR;
`INTRAVENOUS;
`INJECTION
`ANNONIUN CALCIUM ALGINATE
`ORAL; TABLET
`AHMONIUM CHLORIDE
`ORAL; TABLET
`ANNOUIUN HYDROXIDE
`INTRAVENOUS;
`INJECTION
`ORAL; CAPSULE
`INJECTION
`SUOCUTANEOUS;
`ANNONIUN PHOSPHATE, DIBASIC
`ORAL; TABLET
`AMMONIUM SALT 0F C—Iz-C-Is LINEAR PRIMARY ALCOHOL ETNOXYLATE
`TOPICAL; SPONGE
`ANNONIOM SULFATE
`IN - Iv; PONOER, FOR INJECTION SOLUTION
`INTRAVENOUS; SUSPENSION,
`INJECTION
`IV(INFUSION); PONOER, FOR INJECTION SOLUTION
`AMMONYX
`TOPICAL; EMULSION, AEROSOL FOAM
`TOPICAL; SOLUTION
`TOPICAL; SPONGE
`ANPNOTERIC-z
`TOPICAL; SUSPENSION, SHAMPOO
`ANPHOTERIC-s
`TOPICAL; EMULSION, CREAM
`ANETNOLE
`' OENTAL; SOLUTION
`ORAL; SOLUTION
`ORAL; SOLUTION, ELIXIR
`ANIDRISORB 35/70
`ORAL; CAPSULE, SOFT GELATIN
`ANISE EXTRACT
`ORAL; SOLUTION, ELIXIR
`ANISE OIL
`' ORAL; PASTILLE
`ORAL; SOLUTION, ELIXIR
`ORAL; SUSPENSION
`,
`ANISE; STAR
`,
`ORAL; SOLUTION; ELIXI
`ANOXID SBN
`TOPICAL; EMULSION, CREAM
`ANTIFOAM
`ORAL; SUSPENSION
`TOPICAL; LOTION
`
`NOA
`COUNT
`
`LAST
`NOA
`
`APPROVAL
`OATE
`
`DIV POTENCY RANGE
`
`1
`,
`
`3
`
`01/27/95
`01/27/95
`
`600
`600
`
`0.42
`3.4%
`
`06/09/87
`
`600
`
`2_4MG - 4.2MG
`
`05/16/95
`
`600
`
`11/02/87
`
`630
`
`0.4MG
`
`I 1
`
`0/03/83
`
`600
`
`0.0032
`
`34/20/95
`
`UNK
`
`30.045HG - 123.0MG
`
`03/26/76
`
`600
`
`12/16/83
`
`600
`
`10/31/94
`
`600
`
`0.156252
`
`07/16/70
`
`600
`
`0.01% - 0.0312
`
`NHNHHNHNNWNNHHHHWMHHHWHJAHUSHolt)!
`
`CAS A
`
`000631618
`
`012125029
`
`007783280
`
`007783202
`
`004180238
`
`000104461
`
`008007703
`
`008051089
`
`‘1
`
`,
`
`PAGE 6
`
`'
`
`InnoPharma Exhibit 1080.0011
`
`;
`a
`
`
`
`Ill
`
`

`

`INACTIVE INGREDIENTS FOR CURRENTLY MARKETEO DRUG PRODUCTS
`
`.
`
`‘
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`ANTIFOAH DC
`ORAL; POWDER, FOR RECONSTITUTION
`ANTIPYRINE
`OPHTHALMIC; SOLUTION
`AQUACOAT
`ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED,
`AQUACOAT ECD
`ORAL; TABLET, FILM COATED
`AQUAPHOR
`TOPICAL; EMULSION, CREAM
`TOPICAL; OINTMENT
`ARGININE ‘
`INJECTION
`IM -
`IV;
`INTRAVENOUS; POWDER, FOR INJECTION SOLUTION
`IV(INFUSION);
`INJECTION
`ARLATONE 289
`TOPICAL; EMULSION, CREAM
`ASCORBIC ACID
`INJECTION
`CAUDAL BLOCK;
`EPIDURAL;
`INJECTION
`IN -
`IV;
`INJECTION
`INHALATION; AEROSOL, METERED
`INHALATION; SOLUTION
`INTRAMUSCULAR;
`INJECTION
`INTRAVENOUS;
`INJECTION
`INTRAVENOUS; POWDER, FOR INJECTION SOLUTION
`IV(INFUSION);
`INJECTION
`IV(INFUSION); POWDER, FOR INJECTION SOLUTION
`NERVE BLOCK;
`INJECTION
`ORAL; CAPSULE
`ORAL; CONCENTRATE
`ORAL; SUSPENSION, SUSTAINEO ACTION
`ORAL; SYRUP
`ORAL; TABLET
`ORAL; TABLET, FILM COATED
`,RECTAL; SUPPOSITORY
`. SUBCUTANEOUS;
`INJECTION
`ASCORBYL PALMITATE
`ORAL; CAPSULE
`ORAL; TABLET
`RECTAL; SUPPOSITORY
`TOPICAL; EMULSION, CREAM
`ASPARTAME
`ORAL; GRANULE, EFFERVESCENT
`ORAL; POWDER
`ORAL; POWDER, FOR RECONSTITUTION
`ORAL; SYRUP
`
`s
`
`
`
`.
`
`,
`
`CAS #
`
`NDA
`COUNT
`
`LAST
`NOA
`
`APPROVAL
`DATE
`
`DIV POTENCY RANGE
`
`000060800
`
`008029150
`
`000050817
`
`000137666
`
`053906697
`
`PAGE 7
`
`I
`
`0
`
`
`
`HNHHHmwwwwwmmwmwwnwwmmwwmwwwmwwHMNH,Hw
`
`10/03/90
`
`600
`
`03/3T/9? Ann
`
`11/07/95
`
`600
`
`0.78% - 1.56%
`
`0,22
`0.12 - 0.20518Z
`0.02% - 0.038%
`0.12 — 0.22
`
`0.052 ~ 0.22
`
`1.0MG » 28.44MB
`
`07/25/74
`12/28/84
`06/13/91
`04/15/88
`03/09/88
`
`02/16/89
`10/27/83
`
`flfi/77/83
`
`11/15/82
`08/29/88
`
`600
`UNK
`600
`600
`500
`
`500
`600
`
`KOO
`
`600
`600
`
`08/14/87
`
`600
`
`i2/23/91
`
`520
`
`a 162 — 1.052
`
`InnoPharma Exhibit 1080.0012
`
`

`

`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`INSERT, CONTROLLED RELEASE
`
`INJECTION
`
`ASPARTAME
`ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED,
`ASPARTIC ACID
`IV(INFUSION);
`BALSAM CANADA
`TOPICAL; LOTION
`BALSAH, FIR
`TOPICAL; OIL
`BARIUM SULFATE
`INTRAUTERINE; SUPPOSITORY,
`BEESHAX
`ORAL; CAPSULE, SOFT GELATIN
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; TABLET
`ORAL; TABLET, COATED
`TOPICAL; EMULSION, CREAM
`TOPICAL; OINTMENT
`BEESNAX, SYNTHETIC
`TOPICAL; EMULSION, CREAM
`BENTONITE
`ORAL; CAPSULE
`ORAL; SUSPENSION
`ORAL; TABLET
`TOPICAL; SUSPENSION, SHAMPOO
`TRANSDERHAL; FILM, CONTROLLED RELEASE
`AGINAL; SUPPOSITORY
`BENZ LDEHYDE
`ORAL; SUSPENSION
`BENZALKONIUM CHLORIDE
`INHALATION; SOLUTION
`INTRA-ARTICULAR;
`INJECTION
`INTRABURSAL;
`INJECTION
`INTRADERMAL;
`INJECTION
`INTRALESIONAL;
`INJECTION
`INTRAMUSCULAR;
`INJECTION
`NASAL} SOLUTION
`- NASAL: SPRAY
`NASAL; SPRAY, HETERED
`OPHTHALMIC316EL
`OPHTHALMIC; OINTMENT
`OPHTHALMIC; SOLUTION
`OPHTHALMIC; SUSPENSION
`OTIC; SOLUTION
`TOPICAL; LOTION
`TOPICAL; SHAMPOO
`TOPICAL; SOLUTION
`
`
`
`
`4
`
`I”
`
`CAS #
`
`053906697
`
`000056848
`
`008007474
`
`007727437
`
`001302789
`
`000100527
`
`008001545
`
`PAGE 8
`
`NBA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`11/16/94
`
`02/18/94
`
`DIV
`
`UNK
`
`180
`
`POTENCY RANGE
`
`5.41MB ~ 40.0HG
`
`0.4% - 0.682
`
`w»-
`
`N's)IQHhLDm‘JNF‘DFHdPHHHhudmww»~u»nuwwNjnuqnuNw,HNNw
`
`11/22/95
`
`u9/19/69
`12/20/82
`06/30/92
`12/17/90
`
`ISO
`
`LINK
`600
`600
`UNK
`
`“4 .579MG - 18.16MB
`
`0.01/MG - 0.1MB
`0.02MG - 0.53MB
`1.0%
`5.02
`
`16/11/90
`
`01/10/91
`
`600
`
`600
`
`n any
`
`2.12
`
`05/28/93
`
`600
`
`.OIZ - 0.0252
`
`10/20/95
`
`UNK
`
`0.01% - 0.02%
`
`09/29/95
`09/13/95
`01/16/85
`03/28/73
`
`04/11/79
`
`600
`600
`600
`Ann
`
`600
`
`0.000042 - 10.0%
`0.001% - 0.025%
`0.012 - 04022
`0.12
`
`09012
`
`InnoPharma Exhibit 1080.0013
`
`

`

`APPROVAL
`DATE
`
`DIV
`
`POTENCY RANGE
`
`07/16/81
`
`600
`
`10/31/94
`
`600
`
`0,02%
`
`01/29/93
`
`600
`
`04/24/91
`10/10/86
`08/28/81
`01/17/89
`
`09/15/95
`
`UNIfib/Vb
`
`91/04/95
`
`120
`600
`110
`mm
`
`UNK
`
`§£U
`600
`
`DDDC
`
`awnawNifith
`
`0.77
`
`0 17 -
`
`0 2/
`
`12/29/93
`06/30/94
`03/19/82
`03/05/90
`07/25/83
`07/14/87
`
`600
`600
`600
`600
`600
`600
`
`0‘92 - 1.52
`0.0012 - 15.02
`16.4MG ~ 66.9MG
`0.072% — 0.9452
`0.9% - 2.2%
`1.2%
`
`04/09/86
`02/13/74
`
`600
`600
`
`0.001% - 1.0%
`0.9%
`
`InnoPharma Exhibit 1080.0014
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`CA5 A
`
`NDA
`COUNT
`
`' LAST
`NBA
`
`INJECTION
`
`BENZENESULFONIC ACID SOLUTION
`INTRAVENOUS;
`INJECTION
`INTRAVENOUS; SOLUTION,
`IV(INFUSION);
`INJECTION
`BENZETNONIUN CHLORIDE
`IM - IV;
`INJECTION
`INTRAMUSCULAR;
`INJECTION
`INTRAVENOUS; POHDER, FOR INJECTION SOLUTION
`IV(INFUSION);
`INJECTION
`NASAL; SPRAY, METERED
`OPHTHALMIC; POWDER, FOR RECONSTITUTION
`OPHTHALMIC; SOLUTION
`DTIC; SOLUTION
`BENZODODECINIUM BROMIDE
`OPHTHALMIC; SOLUTION
`BENZOIC ACID
`INJECTION
`IM - IV;
`INTRAMUSCULAR;
`INJECTION
`IRRIGATION; SOLUTION
`IV(INFUSION)} INJECTION
`ORAL; SOLUTION
`ORAL; SOLUTION, ELIXIR
`ORAL; SUSPENSION
`ORAL; SYRUP
`ORAL; TABLET, COATED
`TOPICAL; EMULSION, CREAM
`TOPICAL; LOTION
`TOPICAL; SUPPOSITORY
`VAGINAL; EMULSION, CREAM
`VAGINAL; SUPPOSITORY
`BENZOIN
`ORAL; CAPSULE
`ORAL; CAPSULE, SUSTAINED ACTION
`BENZYL ALCOHOL
`INJECTION
`EPIDURAL;
`IM - IV - SC;
`INJECTION
`IM -
`IV;
`INJECTION
`IM - IV; POWDER, FOR INJECTION SOLUTION
`IM -
`IV; SOLUTION,
`INJECTION
`IM - SC;
`INJECTION
`IMT- SC;
`INJECTION, SUSTAINED ACTION
`INTERSTITIAL;
`INJECTION
`INTRA-ARTERIAL;
`INJECTION
`INTRA-ARTICULAR;
`INJECTION
`INTRABURSAL;
`INJECTION
`INTRACAVITARY;
`INJECTION
`INTRACAVITARY; POWDER, FOR INJECTION SOLUTION, LYOPHILI P GE 9
`A
`
`000121540
`
`007281041
`
`000065850
`
`009000059
`
`000100516
`
`
`
`III
`
`
`
`
`
`HyunbpnnmuuumuuowNN‘H;flg~:uumunbmraw>apHmhavruwwuamHFHHN
`
`0 H
`
`Ma
`
`

`

`
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`'
`
`INACTIVE INGREOIENTS FOR CURRENTLY NARKETED DRUG PRODUCTS
`CAS 8
`
`NDA
`COUNT
`
`LAST
`NBA
`
`APPROVAL
`DATE
`
`10/16/87
`10/16/87
`01/27/95
`02/27/85
`
`02/17/84
`05/09/86
`05/09/86
`07/17/98
`
`12/15/95
`10/10/95
`08/30/95
`07/30/93
`
`DIV
`
`UNK
`UNK
`600
`UNK
`
`600
`600
`600
`£00
`
`UNK
`600
`600
`600
`
`POTENCY RANGE
`
`0.9%
`0.9% - 1.0%
`0.0012 - 10.45%
`
`0.92
`0.45% - 0.9%
`0.45% ~ 0.9%
`0.0012 - 3.02
`
`0.9% - 2.02%
`0.9% - 1.5%
`0.752 - 3.0%
`
`12/20/95
`
`520
`
`UB/UZ/bb-
`
`LINK
`
`1.23IMG
`
`01/05/89
`06/19/95
`
`05/29/82
`
`uz/In/uu
`
`09/20/93
`12/07/92
`10/09/85
`
`110
`570
`
`600
`
`OUU
`
`UNK
`UNK
`600
`
`0.09MB ' 1,06MG
`0.96MG - 2,31MG
`
`0.0011 - 0.9%
`n.7n
`
`0.22 - 2.2%
`0.7% ~ 1.0%
`
`12/04/95
`
`600
`
`1.0%
`
`07/30/81
`
`600
`
`0.012 ~ 46.02
`
`InnoPharma Exhibit 1080.0015
`
`28
`
`77
`
`21I1
`
`11
`
`220
`
`1q
`
`Ox
`
`17
`S7
`
`511
`
`36
`
`1911132141q1
`
`30
`
`9311161 8 1
`
`’. BENZYL ALCOHOL
`INJECTION
`INTRADERMAL;
`INTRALESIONAL;
`INJECTION
`INTRAMUSCULAR;
`INJECTION
`INTRAMUSCULAR; POWDER, FOR INJECTION SOLUTION
`INTRAMUSCULAR; SOLUTION,
`INJECTION
`INTRAPERITONEAL;
`INJECTION
`INTRAPLEURAL;
`INJECTION
`INTRASYNOVIAL;
`INJECTION
`INTRATNECAL;
`INJECTION
`INTRATUMOR;
`INJECTION
`INTRAVENOUS} INJECTION
`INTRAVENOUS; POWDER, FOR INJECTION SOLUTION
`INTRAVENOUS; SOLUTION,
`INJECTION
`IV - SC;
`INJECTION
`IV(INFUSION);
`INJECTION
`IV(INFUSION); POWDER, FOR INJECTION SOLUTION
`IV(INFUSION); SOLUTION,
`INJECTION
`NERVE BLOCK;
`INJECTION
`ORAL; CAPSULE
`ORAL; CAPSULE; SOFT GELATIN
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; CONCENTRATE
`ORAL} SOLUTION
`ORAL; SUSPENSION
`ORAL; TABLET
`ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
`ORAL; TABLET. SUSTAINED ACTION
`SOFT TISSUE;
`INJECTION
`SUBCONJUNCTIVAL;
`INJECTION
`SUBCUTANEOUS;
`INJECTION
`SUBCUTANEOUS} POWDER; FOR INJECTION SOLUTION
`TOPICAL; EMULSION, CREAM
`TOPICAL; LOTION
`TOPICAL; OINTMENT
`TOPICAL; SOLUTION
`TOPICAL; SUPPOSITORY
`URETERAL; SOLUTION
`VAGINAL; EMULSION, CREAM
`VAGINAL; SUPPOSITORY
`BENZYL BENZOATE
`INTRAMUSCULAR;
`BENZYL CHLORIDE
`INTRAVENOUS;
`
`INJECTION
`
`INJECTION
`
`1N
`
`000100516
`
`000120514
`
`000100447
`
`PAGE 10
`
`

`

`
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`CAS 3
`ND A
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV
`
`POTENCY RANGE
`
`.052 - 2.02
`.62 - 1‘02
`
`O0
`
`01/13/76
`
`600
`
`04/02/63
`12/29/95
`12/28/82
`02/25/94
`
`UNK
`600
`600
`600
`
`11/26/82
`
`600
`
`08/08/85
`
`S10
`
`.OOUSZ
`
`11/22/95
`
`150
`
`.IMG - 0.2MG
`
`10/31/91
`
`08/31/92
`04/16/81
`12/23/82
`09/30/83
`04/26/93
`01/04/95
`
`04/26/93
`
`600
`
`600
`600
`UNK
`UNK
`520
`Ann
`
`520
`
`C)
`
`UQDC
`
`3
`
`.04MG - OISMG
`
`.1u23nu - DIZISHG
`.SMG
`.DOSZZ
`.OOSZ - 0.02%
`
`nnl72 - 0.00442
`
`AOMG
`
`08/08/85
`
`510
`
`.0012
`
`InnoPharma Exhibit 1080.0016
`
`INJECTION
`
`BETA-NAPNTHOL
`ORAL; CAPSULE
`BORIC ACID
`INJECTION
`INTRAVENOUS; SOLUTION,
`OPHTHALMIC; POWDER, FOR RECONSTITUTION
`OPHTHALMIC; SOLUTION
`OPHTHALMIC; SUSPENSION
`OTIC; SOLUTION
`TOPICAL; SHAMPOO
`BUFFER, ACETIC ACID—SODIUM ACETATE
`IM - IV - SC;
`INJECTION
`INTRA-ARTICULAR;
`INJECTION
`INTRAMUSCULAR;
`INJECTION
`INTRASYNOVIAL;
`INJECTION
`IV(INFUSION);
`INJECTION
`BUFFER, CITRIC ACID-SODIUM CITRATE
`IH -
`IV;
`INJECTION
`IV(INFUSION);
`INJECTION
`SUBCUTANEOUS; SOLUTION,
`BUTANE
`TOPICAL; AEROSOL SPRAY
`TOPICAL; EMULSION, AEROSOL FOAM
`BUTYL ALCOHOL, TERTIARY
`TOPICAL; GEL
`BUTYEATED HYDROXYANISOLE
`INTRAMUSCULAR;
`INJECTION
`IV(INFUSION);
`INJECTION
`NASAL; SPRAY, METERED
`ORAL: CAPSULE
`ORAL; CAPSULE, SOFT GELATIN
`ORAL; CONCENTRATE
`ORAL; GRANULE, FOR RECONSTITUTION
`ORAL; TABLET
`ORAL; TABLET, FILM COATED
`RECTAL; SUPPOSITORY
`SUBLINGUAL; TABLET
`TOPICAL; EMULSION, CREAM
`TOPICAL; OINTMENT
`TOPICAL; SUPPOSITORY
`VAGINAL; EMULSION, CREAM
`VAGINAL; OINTMENT
`VAGINAL; SUPPOSITORY
`BUTYLATED HYDROXYTOLUENE
`INHALATION; LIQUID
`INTRAMUSCULAR;
`INJECTION
`IV(INFUSION);
`INJECTION
`NASAL; SPRAY, METERED
`
`
`
`
`
`1"
`
`000135193
`
`010043353
`
`000106978
`
`000075650
`
`008003245
`
`000128370
`
`PAGE 11
`
`
`
`
`
`(NHNHHNNmNBNNmeHHNWL—ONHHw»yaw-HHHNHHHN‘NU’iOU-nN
`
`

`

`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`DIV
`
`410
`
`600
`
`bUU
`
`unx
`UNK
`UNK
`UNK
`
`POTENCY RANGE
`
`n n1sma —
`
`0 7mm
`
`0,1MG ~ n.4MG
`
`0.0125MU - 0,210m6
`.uzz — 0.1%
`.052
`.022
`.ORZ
`
`QDGCZ
`
`NDA
`c0001
`
`LAST
`NBA
`
`APPROVAL
`DATE
`
`nn/17/7n
`
`12/11/87
`
`05/31/92
`
`11/(0/3d
`10/05/78
`06/15/77
`05/04/77
`
`215141722211
`
`1
`
`12/20/95
`02/14/94
`
`520
`600
`
`U9/ZS/TQ
`
`$20
`
`0,0058%
`
`09/17/69
`03/31/81
`11/14/94
`
`04/21/99
`12/17/81
`12/23/83
`
`120
`UNK
`UNK
`
`DUO
`600
`600
`
`30¢
`
`CDflC
`
`.OOZBMG ~ 0.004MG
`.OD6MG
`1OAMG
`
`.22 - 0.4%
`.022
`.182 2 0.3%
`
`04/12/88
`02/09/89
`09/28/92
`
`600
`600
`600
`
`8.0MG ~ 8.3MG
`8.3MG - 10.0MG
`
`12/31/93
`
`510
`
`125.68MG - 224.7MG
`
`04/16/91
`
`600
`
`4.17MB - 60.0MG
`
`InnoPharma Exhibit 1080.0017
`
`CAS 2
`
`000120370
`
`000107880
`
`000094260
`
`’
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`INJECTION
`
`BUTYLATED HYDROXYTOLUENE
`ORAL; CAPSULE
`ORAL; CAPSULE, SOFT GELATIN
`ORAL; TABLET
`ORAL; TABLET, SUSTAINED ACTION
`RECTAL; SUPPOSITORY
`TOPICAL; EMULSION, AEROSOL FOAM
`TOPICAL; EMULSION, CREAM
`TOPICAL: GEL
`TOPICAL; OINTMENT
`TOPICAL: SOLUTION
`VAGINAL; EMULSION, CREAM
`VAGINAL; SUPPOSITORY
`BUTYLENE GLYCOL
`TRANSDERMAL; FILM, CONTROLLED RELEASE
`BUTYLPARABEN
`INTRAMUSCULAR;
`ORAL; CAPSULE
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; DROPS
`ORAL; SOLUTION
`ORAL; SUSPENSION
`ORAL; SYRUP
`ORAL; TABLET
`ORAL; TABLET, COATED
`ORAL; TABLET, REPEAT ACTION
`ORAL: TABLET, SUSTAINED ACTION
`RECTAL; SOLUTION
`TOPICAL; EMULSION, CREAM
`TOPICAL; LOTION
`TOPICAL; OINTMENT
`CAFFEINE
`OPHTHALMIC; SOLUTION
`CALCIUM
`IM ‘ IV} INJECTION
`INTRAMUSCULAR;
`INJECTION
`CALCIUM ACETATE
`' ORAL-21; TABLET
`ORAL‘ZB; TABLET
`TOPICAL; EMULSION, CREAM
`CALCIUM ASCORBATE
`ORAL; SUSPENSION
`CALCIUM CARBONATE, PRECIPITATED
`ORAL; CAPSULE
`ORAL; CAPSULE, HARD GELATIN
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; TABLET
`
`
`
`1
`28
`
`411q i
`
`3251s33
`
`1
`
`11
`
`353
`
`1
`
`211
`
`32
`
`000050082
`007440702
`
`000062544
`
`005743271
`000471341
`
`PAGE 12
`
`

`

`
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`NBA
`COUNT
`
`LAST
`NBA
`
`APPROVAL
`DATE
`
`DIV
`
`PUTENCY RANGE
`
`02/25/92
`
`600
`
`0.72MB - 64.8MG
`
`08/19/91
`
`UNK
`
`87.5MG ~ 229.7MG
`
`02/25/94
`
`600
`
`0.382%
`
`12/01/86
`05/07/83
`
`600
`snn
`
`UQ/28/95
`
`600
`
`12/01/ub
`99/22/93
`04/27/33
`
`can
`UNK
`@99
`
`.0332
`0052
`
`DD
`0.0932
`
`n.0242 - 0.0332
`
`0.0082
`
`11/18/93
`01/15/70
`OBITS/7A
`
`12/30/81
`12/30/81
`
`21.5MG - 160.0MG
`
`‘7 ENG - 362.0MG
`
`82.9MG - 86.0MG
`86.0MG
`2
`
`04/10/84
`04/18/62
`
`600
`120
`
`1.8MG - 2.4MG
`5.0MG - 234.04MG
`
`11/30/95
`
`ICIZU/UZ
`
`600
`
`bUU
`
`n AZIMG — n50_gHG
`
`55.0MG - 168.0MG
`
`InnoPharma Exhibit 1080.0018
`
`18
`
`2
`
`22
`
`1131I2 I3SI2I6221I I 1I I I334122 1 221I4I
`
`10
`
`I1
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`CALCIUM CARBONATE, PRECIPITATED
`ORAL; TABLET, COATED
`ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
`ORAL; TABLET, FILM COATED
`ORAL; TABLET, SUSTAINED ACTION
`ORAL-21; TABLET
`ORAL-28; TABLET
`OTIC; SOLUTION
`CALCIUM CHLORIDE
`INJECTION
`CAUDAL BLOCK;
`EPIDURAL;
`INJECTION
`IN - IV;
`INJECTION
`INTRAMUSCULAR;
`INJECTION
`INTRAOCULAR; SOLUTION
`INTRAPERITONEAL; SOLUTION
`NERVE BLOCK;
`INJECTION
`OPHTHALMIC; POWDER, FOR RECONSTITUTION
`OgAL; CONCENTRATE
`0 AL; SUSPENSION
`SUBCUTANEOUS;
`INJECTION
`CALCIUM GLUCEPTATE
`INTRAVENOUS;
`INJECTION
`CALCIUM HYDROXIDE
`ORAL; SUSPENSION
`TOPICAL; EMULSION, CREAM
`CALCIUM LACTATE
`VAGINAL; TABLET
`CALCIUM PHOSPHATE
`ORAL; CAPSULE
`ORAL; TABLET
`ORAL; TABLET, COATED
`ORAL; TABLET, FILM COATED
`ORAL; TABLET, REPEAT ACTION
`ORAL-213 TABLET
`ORAL-28; TABLET
`CALCIUM PHOSPHATE DIBASIC DIHYDRATE-SUCROSE AGGLDMERATE
`. ORAL; TABLET
`CALCIUM PHOSPHATE, DIBASIC
`ORAL: CAPSULE
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; PASTILLE
`ORAL: SYRUP
`,
`ORAL; TABLET
`ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED,
`ORAL; TABLET, COATED
`ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
`ORAL; TABLET, DISPERSIBLE
`
`‘
`
`0
`
`CA5 A
`
`000471301
`
`010035048
`
`017140602
`
`001305620
`
`00081A802
`
`010103465
`
`007757939
`
`PAGE 13
`
`
`
`
`
`TH
`
`

`

`
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`NDA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`12/12/95
`08/21/92
`04/12/88
`02/09/89
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`CALCIUM PHOSPHATE, DIBASIC
`ORAL; TABLET; FILM COATED
`ORAL; TABLET, SUSTAINED ACTION
`ORAL-21; TABLET
`ORAL-28} TABLET
`TOPICAL; SHAMPOO
`CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
`ORAL; CAPSULE
`ORAL; TABLET
`ORAL; TABLET, COATED
`ORAL; TABLET, FILM COATED
`ORAL; TABLET, SUSTAINED ACTION
`CALCIUM PHOSPHATE; TRIBASIC
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; TABLET
`COATED
`ORAL; TABLET;
`ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
`ORAL; TABLET, SUSTAINED ACTION
`ORAL-28; TABLET
`CALCIUM PYROPHOSPHATE
`ORAL; TABLET
`CALCIUM SILICATE
`ORAL; TABLET
`ORAL; TABLET; COATED
`ORAL; TABLET, SUSTAINED ACTION
`CALCIUM STEARATE
`ORAL; CAPSULE
`ORAL; CAPSULE;
`ORAL; TABLET
`ORAL; TABLET (IMMED./COMP. RELEASE),
`FILM COATED
`ORAL; TABLET;
`SUSTAINED ACTION
`ORAL; TABLET,
`SUBLINGUAL; TABLET
`CALCIUM SULFATE
`ORAL; CAPSULE
`ORAL; CAPSULE, SUSTAINED ACTION
`. ORAL; SYRUP
`ORAL; TABLET
`ORAL; TABLET, COATED
`FILM COATED
`ORAL; TABLET;
`ORAL; TABLET, REPEAT ACTION
`SUSTAINED ACTION
`ORAL; TABL