|nnoPharma Exhibit 1080.0001
`
`

`

`
`
`defines inactive i
`
`”inactive
`s foiiows:
`nd active ingredients a nent that is intended‘
`ngredients a
`y compo
`redient means an
`
`n approved drug products or conditionaily
`Purpose The Inactive Ingredient Guide contains all inactive ingredients present i
`approved drug products currently marketed for human use. The Guide is compiled by the Division of Drug information
`R/CBER Reviewers with information on inactive ingredients in products which have been
`ears in a currentiy approved drug product for a particuiar route of
`Resources iDDlRl.
`it provides CDE
`tive ingredient app
`uid not usuaily b
`d may require a
`Agency. Once an inac
`approved by the
`by route of administration
`e inactive ingredient wo
`administration, th
`iiy by ingredient, and then labeling.
`e has been sorted first a
`derived from current approved
`ctive Ingredient Guidtration and dosage forms are
`Design The fna
`f adminis
`and dosage form. Routes o
`
`e considered new an
`
`less extensive review.
`
`Definitions
`
`21 CFR 210.3
`
`lbi(8,7, respectiveiyi
`
`ingredient means any component other than the active ingredient. Active ing
`gical activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease,
`an or animals. The term tactive ingredient) includes those
`in the finished drug
`and be present
`to furnish pharmacolo
`unction of the body of in
`ture of the drug product
`ption of the CFR definition, inactive
`ture or any f
`change in the manufac
`or to affect the struc
`ity or effect." As an exce
`dergo chemical
`product.
`the specified activ
`t in the iinai dosage form of the drug
`components that may un
`ed to furnish
`product in a modified form intend
`4
`ose which are presen
`iy th
`Since many ingredients have
`DER.
`ingredients iisted in the Guide include on
`ormation Officer
`tact your Drug inf
`il ingredients contain
`DDIR maintains a dictionary of a
`edienr Guide),
`synonyms iw
`‘
`the Inactive /ngr
`ar inactive ingredient.
`
`
`
`Synonyms
`
`ed in submissions to C
`it may assist you to con
`
`if you cannot
`
`active ingredients ie.g.,
`nts of proprietary in you may have to search
`clients are included,
`DDiR does not aiways inc
`ingredients
`ch situations where components of proprietary inactive ingre
`Proprietary inactive
`OPACODESl.
`in so
`cturer. Some
`component entries.
`nded as such by the rnanufa (see 21 CFR
`for such data under individuai
`e ingredients specifically inte
`t circumstances
`edient Guide iists inactiv
`dients under differen
`My or chernicaily
`which physica
`o be considered as active ingre
`Warnings The Inactive Ingr
`f this Guide.
`in radiopharmaceuticai kits, or inactive ingredients
`of these inactive ingredients could als
`for the purposes 0
`ort are considered ‘as inactive ingredients
`210.3(bl(7,3ll. Furthermore, reactants
`combine with active ingredients to faciiitate drug transp
`
`lude the cornpone
`
`iContinued]
`
`
`
`|nnoPharma Exhibit 10800002
`
`

`

`
`
`Contaminants The /nacrive /ngred/ent Guide does not represent contaminants found in approved drug products.
`
`if any of the inactive ingredients represented in the Inactive /ngredfenr Guide are proven to be
`Carcinogens and Teratogens
`carcinogenic, teratogenic, or embryotoxic, please notify DDIR immediately. DDlR will attempt to relay your concern to each
`rnedicai officer and pharmacologist reviewer responsible for oversight of other approved drug products which contain the
`specified inactive ingredient.
`
`CAS Number Many inactive ingredients have Chernicai Abstracts Service 7{CA[’Sg/i numbers associated with them. These can
`be found in the column to the right of the inactive ingredient. CA8 numbers rnayggbe helpful to CIDER/CBER Reviewers when
`initiating computer-assisted searches with the National Library of Medicine's :online data bases.
`
`Qualitative NDA Data The next five columns to the right of the CAS numberjserve to qualify the data presented. The NBA
`
`CT‘ reflects the total number of NDAs in which a particular inactive ingredieng
`'*rently appears. The ‘Last NDA’ specifies
`which NDA was the most recent one to be approved by the Agency with thisziinactrve ingredient. The ’APPRO‘./AL DATE‘ and
`‘DIV’ specify the approval date and Review Division responsible for evaluating this most recent NDA. 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 coilapsed 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, provisionaily iisted,
`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 /nacr/ve /ngred/enr 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.
`
`|nnoPharma Exhibit 1080.0003
`
`

`

`
`
`DIVISION OF DRUG iNFORMATION RESOURCES
`
`DRUG INFORMATION OFFICERS
`
`Division of Carciio-Renai Drug Products, HFD4 i0 .
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`Division of Neuropharmacoiogicai Drug Products, HFD-120 .
`Division of Oncoiogic Drug Products, HFD-1 50 .
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`Division of Medicai Imaging, Surgicai, and Dental Products, HFD-160 .
`Division of Anesthesia, Criticai Care, and Addiction Drug Products, HFD-170 .
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`, Diane Centeno—Deshieids, R.Ph.
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`. Diane Centeno-Deshieids, R.Ph.
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`, Sharon Browneweii
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`, .Herbert Thornton, R.Ph.
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`. Mary Guiiderson
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`. Richard Lioov, R.Ph
`
`Division of Gastrointestinai and Coaguiatiorr Drug Products, HFD4 80 ,
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`Division of Metabolism and Endocrine Drug Products, HFD-510 ,
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`’ Division of Anti—Infective Drug Products, HFD—52O .
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`, Mark W. Askine, R.Ph.
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`Division of Antivirai Drug Products, HFD—53O
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`. Mark W. Askine, R.Ph
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`. Mary Guilderson
`
`. Sharon Browneweii
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`Division of Puimonary Drug Products, HFD-570 .
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`. .Janet Anderson, R,Ph.
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`AII DDIR Drug information Officers can be contacted at 443-0500 and are iocated in Room 218 of the Chapman Building.
`
`|nnoPharma Exhibit 1080.0004
`
`

`

`
`
`INACTIVE INGREDIENT FIELD DESCRIPTION
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`ACACIA
`
`CAS#
`
`009000015
`
`BUCCAL/SUBLINGUAL: TABLET
`ORAL; CAPSULE
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; POWDER
`
`ingredient Chernicai substance added to enhance formulation 0! 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,
`
`CASI9‘ Registry number assigned to a compound by Chemical Abstracts
`Service on a random basis.
`
`NDA
`COUNT
`
`LAST
`NDA
`M85125
`N85296
`M17078
`N16640
`
`APPROVAL
`DATE
`02/02/77
`04/01/77
`08/02/76
`08/03/73
`
`DIVISION
`600
`600
`120
`510
`
`FOTENCY
`RANGE
`40 « 9,1 MG
`
`001- 0.7 MG
`21.0%
`
`NDA Count Reiiects total number of approved NDAs in which a parti«
`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 approval date and the Review
`Division responsibie for evaiuating this most recent NDA.
`
`Specifies the minimum and maximum amounts of
`Potency Range
`inactive ingredients for each route/dosage form.
`
`|nnoPharma Exhibit 1080.0005
`
`

`

`
`
`.
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`CAS 3
`NDA
`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-Z8; TABLET
`ACACIA HUCILAGE
`ORAL; TABLET, COATED
`ACETIC ACID
`INJECTION
`IM - 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; POWDER, FOR INJECTION SOLUTION
`IM - 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
`NASAL2 SOLUTION
`NASAL; SPRAY, METERED
`OPHTHALMIC; SOLUTION
`ORAL; CAPSULE, HARD GELATIN
`
`,
`
`1
`‘
`
`E
`
`:11
`
`OO9000O15
`
`OO8047389
`
`OOOO64197
`
`PAGE I
`
`
`
`WmwpnuwhnuuhduuhbundwrdmwawhuawwnoounawwbhHNN\nuHnu»whn-wuuw
`
`id
`
`N
`
`O3/O8/88
`
`ADO
`
`09/29/95
`07/29/92
`O2/25/92
`
`05/15/85
`03/31/81
`O1/O4/95
`10/01/76
`03/29/76
`
`6OO
`600
`EOO
`
`sou
`UNK
`600
`510
`510
`
`0.03GH
`3.22NG ~ 80.0MG
`0.02MG - 156.0MG
`
`0.04MG - 0.08MG
`I1.S4ZMG
`2.0MG - 34.4MG
`I.Z6MG
`1.26MB
`
`07/09/80
`07/31/90
`03/25/94
`
`510
`600
`16O
`
`0.046Z
`0.027Z — 0.442
`
`O5/O2/B8
`
`OQ/IQ/95
`
`Ob/OI//B
`05/02/88
`05/07/78
`03/17/94
`
`EOO
`
`bUU
`
`bUU
`600
`6OO
`UNK
`
`0.135% - 0,25%
`
`0.012 ~ 0.48%
`
`0.006Z ~ 0.044ZZ
`
`0,012 - 0.225%
`
`AU/ZI/95
`
`510
`
`0.122 - 0.4352
`
`|nnoPharma Exhibit 1080.0006
`
`

`

`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`CAS #
`
`OOOO64197
`
`OOD108247
`
`000540921
`
`OOO616911
`
`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
`ACETYLATEO MONOGLYCERIDES
`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-200
`ORAL: TABLET
`ORAL; TABLET, FILM COATED
`r
`AEROTEX RESIN 3730
`AIR TRANSDERMAL; FILM, CONTROLLED RELEASE
`1NHALAT1oN;’sAs
`ALBUMIN AGGREGATED
`.
`INTRAVENOUS;
`INJECTION
`ALBUMIN COLLOIDAL
`INTRAVENOUS; POWDER, FOR INJECTION SOLUTION
`
`E
`%
`,
`
`HI
`
`,
`
`PAGE 2
`
`NDA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV
`
`POTENCY RANGE
`
`
`
`
`
`y.aNmxwmNHrvoNwwAtuohnowrawNwu~wsambaHNADJHR).
`
`12/16/85
`
`600
`
`0.07SZ - 0.1%
`
`11/06/85
`O6/12/91
`
`600
`510
`
`.362
`
`DC3
`
`05/30/81
`11/15/79
`
`£60
`500
`
`(‘SIG-
`
`>-'-EMNN
`
`II
`
`311')
`
`NW NO
`
`01/10/92
`
`110
`
`2.0MG ~ 9,0MG
`
`U4/ZI/91
`D4/26/78
`03/29/82
`02/02/87
`05/14/85
`
`11/22/83
`
`600
`600
`600
`600
`UNK
`
`600
`
`0.0fiMG - 2.7MG
`
`.92MG - 5.17MG
`.O4MG - 2.1MG
`
`DIN)
`
`08/17/88
`02/02/87
`
`600
`600
`
`D.1MG ‘ 9.0MG
`S.6MG - 7.2MG
`
`1
`
`10/01/82
`
`12/30/87
`
`I60
`
`160
`
`0.0252
`
`|nnoPharma Exhibit 1080.000?
`
`

`

`
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`zusnsnzeur
`ROUTE/DOSAGE roan
`
`INJECTION
`
`ALBUNIN HUMAN
`INJECTION
`INTRAVENOUS;
`INTRAVENOUS; POWDER, FOR INJECTION SOLUTION
`IV(INFUSION);
`INJECTION
`ALCOHOL
`DENTAL) SOLUTION
`IM - IV;
`INJECTION
`INJECTION
`IM - IV; SOLUTION,
`INHALATION; AEROSOL, METEREO
`INHALATION; SOLUTION
`INTRAMUSCULAR;
`INJECTION
`INTRAVENOUS} INJECTION
`IV - SC;
`INJECTION
`IV(INFUSION)3 INJECTION
`IV(INFUSION); SOLUTION,
`OPNTHALMIC; SOLUTION
`ORAL} AEROSOL SPRAY
`ORAL: CONCENTRATE
`ORAL; SOLUTION
`ORAL} SOLUTION, ELIXIR—
`ORAL; SUSPENSION
`ORAL; SYRUP
`RECTAL; SUSPENSION
`TOPICAL; AEROSOL SPRAY
`TOPICAL; GEL
`TOPICAL} LOTION
`TOPICAL; SOLUTION
`TRANSDERMAL; FILM, CONTROLLED RELEASE
`VAGINAL; EMULSION, CREAM
`ALCOHOL; DENYORATED
`IH - IV;
`INJECTION
`IM - IV; POHDER, FOR INJECTION SOLUTION
`INHALATION; AEROSOL, METERED
`INTRAMUSCULAR;
`INJECTION
`INTRAVASCULAR;
`INJECTION
`INTRAVENOUS}
`INJECTION
`IV(INFUSION):
`INJECTION
`IV(INFUSION); POWDER, FOR INJECTION SOLUTION
`IV(INFUSION); SOLUTION,
`INJECTION
`NASAL5 AEROSOL SPRAY
`NASAL} AEROSOL; METERED
`OPHTHALMIC; SOLUTION
`ORAL; CONCENTRATE
`ORAL; SOLUTION
`ORAL! SOLUTION. ELIXIR
`ORAL; SUSPENSION
`ORAL; SYRUP
`
`_
`
`
`
`
`
`CA5 :
`
`009005535
`
`000064175
`
`OOOO64175
`
`PAGE 3
`
`NDA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV
`
`POTENCY RANGE
`
`HwHvm>-whJam»HaAH540
`
`3-“1-‘\amOunmhM~H»nwNUw~N$U~Nwuunmhaw
`
`12/28/90
`
`510
`
`0.05% - 1.2%
`
`12/28/95
`O1/29/93
`
`600
`600
`
`10.02 - 12.152
`8.55% - 11402
`
`12/Z8/UH
`
`UHK
`
`au.u4 - 38.02
`
`O2/IO/94
`
`O8/SO/95
`12/31/86
`
`08/30/91
`11/17/95
`04/29/93
`59/15/95
`10/28/94
`11/17/86
`
`06/13/90
`07/03/85
`02/27/95
`09/29/95
`
`IO/13/B7
`
`nu/zs/uz
`11/30/89
`
`07/11/95
`O8/30/95
`
`10/11/88
`11/30/94
`07/14/95
`01/25/82
`06/18/87
`11/22/85
`
`600
`
`6OO
`I10
`
`600
`530
`600
`I80
`600
`800
`
`UNK
`600
`600
`S10
`
`6OO
`
`UHK
`UNK
`
`6UU
`600
`
`600
`600
`530
`600
`600
`600
`
`6.82 - 30.5%
`
`O.b1Z - 52.92
`10.0% ~ 30.02
`
`.8192 - 71.6%
`.23Z - 30.02
`.OZ ~ 20.42
`.OOO0O67Z - 7.252
`.52 ' 7.5%
`
`DDUTQO
`
`52.02
`71.02 ~ 80.52
`33.0% - 83.0%
`
`fl.OIZ ~ I0.0Z
`
`l.OZ - 34.5482
`10,02
`
`5.02 - 50.0%
`10.0% - 80.02
`
`0.52
`0.00003Z - 7.37%
`0.12 - 24.92
`12.0% - 20.02
`0.262 ’ 1.0%
`5.02 - 7.0%
`
`|nnoPharma 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; POHDER, 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
`OTICi SOLUTION
`TOPICAL; EMULSION, CREAM
`TOPICAL; SHAMPOO
`ALUMINUM NYDROXIDE
`TOPICAL; EMULSION, CREAM
`TOPICAL; NINTMENT
`
`,
`
`CAS 3
`
`000064175
`
`008024451
`
`O08000166
`
`099005327
`
`OOOO97596
`
`090139123.
`
`fl01302290
`
`PAGE 4
`
`
`
`HI
`
`NOA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`01/29/93
`??/?§/90
`
`DIV
`
`600
`600
`
`POTENCY RANGE
`
`“x”,
`
`20.DZ - 94.78082
`55.02 - 77.0%
`
`
`
`
`
`BabwhimwhuewwhuuwamrumrdwHr4w%dNu¢HNlhbunwnawHump
`
`10/26/84
`01/11/91
`07/30/93
`
`UNK
`600
`600
`
`75.352 — 9s.93esz
`44.oz ~ so.1sz
`75.02
`
`O5/16/79
`
`D8/Z1//8
`
`SOO
`
`600
`
`6.€1767
`
`O.5Z ' 1.52
`
`U5/14/86
`12/29/94
`06/28/39
`
`690
`110
`600
`
`17.0MG
`0.07MG - 3O.OHG
`390 ONO - 400.0MG
`
`U9/U3/BO
`
`6OU
`
`16.BOQMG ~ 52.8MG
`
`12/22/87
`10/10/85
`
`600
`600
`
`5.0%
`
`|nnoPharma Exhibit 1080.0009
`
`

`

`
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`CAS 3
`
`NBA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV
`
`POTENCY RANGE
`
`
`
`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 HYOROXIDE GEL F 5000
`TOPICAL; EMULSION, CREAM
`ALUMINUM HYDROXIDE GEL, DRIED
`ORAL; TABLET
`‘
`ALUMINUM OXIDE
`ORAL} TABLET
`ALUMINUM POLYESTER
`TRANSDERMAL3 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; NUSPENSION
`
`012040594
`
`008012633
`
`001344281
`
`012141467
`
`007047849
`
`010043013
`
`009002191
`
`008029047’
`
`007664417
`
`008007576
`
`PAGE 5
`
`
`
`>3hi|\)L]!)-4)-‘OF-3P-"DIR)|\)UJF-JP-‘I-6L-‘I-it-ID—'D--‘F--‘D-AIN)IS)13>-4
`
`
`
`
`
`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
`
`I.0MG - 12.0MG
`
`08/25/89
`
`12/03/86
`
`UNK
`
`600
`
`1.02 - 5.02
`
`|nnoPharma Exhibit 1080.001O
`
`

`

`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`mm
`COUNT
`
`LAST
`man.
`
`APPROVAL
`one
`
`nxv
`
`PUTENCY 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
`
`600
`
`0.4MG
`
`a 1
`
`0/03/83
`
`600
`
`0.0032
`
`O4/20/95
`
`UNK
`
`30.045MG -
`
`I23.0MG
`
`03/26/76
`
`600
`
`12/16/83
`
`600
`
`10/31/94
`
`600
`
`0.156252
`
`07/16/70
`
`600
`
`0.01% - 0.0312
`
`
`
`
`
`
`
`IV)‘-Al\)5-‘F-’!\)D-4H.)I\)U1)*‘>-‘D-0>-I)-v¢>-It-ID-‘F-I)-1V-4D.)D-J.I.\)-iUxr-IDID}
`
`'
`
`’
`
`‘
`
`measnmn
`ROUTE/DOSAGE FORM
`AMMONIUM ACETATE
`INJECTION
`INTRAMUSCULAR;
`INTRAVENOUS;
`INJECTION
`AMHONIUN CALCIUM ALSINATE
`ORAL; TABLET
`AHHONIUM CHLORIDE
`ORAL; TABLET
`AMMONIUM HYOROXIDE
`INTRAVENOUS;
`INJECTION
`ORAL; CAPSULE
`INJECTION
`SUBCUTANEOU5;
`AMMOHIUM PHOSPHATE, DIBASIC
`ORAL: TABLET
`AMMONIUM SALT OF C-12-C-IS LINEAR PRIMARY ALCOHOL ETHOXYLATE
`TOPICAL; SPONGE
`AMMONIUH SULFATE
`IN - IV; POHDER, FOR INJECTION SOLUTION
`INTRAVENOUS} SUSPENSION,
`INJECTION
`IV(INFUSION); POWDER, FOR INJECTION SOLUTION
`AMNONYX
`TOPICAL: EMULSION. AEROSOL FOAM
`TOPICAL; SOLUTION
`TOPICAL; SPONGE
`AMPHOTERIC-2
`TOPICAL; SUSPENSION, SHAMPOO
`AMPHOTERIC-6
`TOPICAL} EMULSION; CREAM
`ANETHOLE
`‘ DENTAL; SOLUTION
`ORAL: SOLUTION
`ORAL; SOLUTION, ELIXIR
`ANIDRISORB 85/70
`ORAL; CAPSULE. SOFT GELATIN
`ANISE EXTRACT
`ORAL; SOLUTION, ELIXIR
`ARISE OIL
`' ORAL} PASTILLE
`ORAL; SOLUTION; ELIXIR
`ORAL; SUSPENSION
`.
`ANISE, STAR
`.
`ORAL; SOLUTION, ELIXI
`ANOXIO SBN
`TOPICAL; EMULSION. CREAM
`ANTIFOAM
`ORAL; SUSPENSION
`TOPICAL; LOTION
`
`I
`
`czzs 4
`
`noossxsm
`
`012125029
`
`007783280
`
`007783202
`
`004180238
`
`000104461
`
`008007703
`
`008051089
`
`‘f
`
`PAGE 6
`
`'
`
`|nnoPharma Exhibit 1080.0011
`
`E
`
`
`
`Ill
`
`

`

`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG FRODUCTS
`
`.
`
`CAS 9
`
`LAST
`mm
`cmmr mm
`
`APPROVAL
`mm-:
`
`mu
`
`POTENCY RANGE
`
`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
`IN -
`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 PALNITATE
`ORAL; CAPSULE
`ORAL; TABLET
`RECTAL; SUPPOSITORY
`TOPICAL; EMULSION, CREAM
`AspAgTAME
`ORAL; GRANULE, EFFERVESCENT
`ORAL; POWDER
`ORAL; POWDER, FOR RECONSTITUTION
`ORAL; SYRUP
`
`A
`
`.
`
`7
`
`2
`
`
`
`000060800
`
`O08029I5O
`
`000650817
`
`I
`
`1
`
`000137666
`
`053906697
`
`PAGE 7
`
`
`
`
`
`
`
`
`
`P-'l’\))-ID--I)-lU'I¥d7-0D-J5-0)-3U\f\)P-‘\)‘\>-')'-'f\)UJ>'-‘O\LJ1r-4\If\))-‘V-1D-MOI)-‘(MI-I)-M|\))--l,Hi#4
`
`10/03/90
`
`600
`
`O3/3T/9? Ann
`
`11/07/95
`
`600
`
`0.78% * 1.56%
`
`07/25/74
`12/28/84
`06/13/91
`04/15/88
`03/09/88
`
`0.2%
`600
`UNK O.1Z - 0.245182
`600
`0.02% — 0.0382
`600
`0.1% ~ 0.22
`600
`
`92/16/89
`10/27/83
`
`bUU
`600
`
`flfi/77/R3
`
`11/15/82
`08/29/88
`
`500
`
`600
`600
`
`08/14/87
`
`600
`
`0,052 ~ 0,22
`
`1.0MG ‘ R8.44MG
`
`i2/23/91
`
`520
`
`0.152 — 1.052
`
`|nnoPharma Exhibit 1080.0012
`
`

`

`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`NBA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`11/16/94
`
`02/18/94
`
`DIV
`
`UNK
`
`180
`
`POTENCY RANGE
`
`5.41MB - 40.0MG
`
`0.4% - 0.682
`
`F-0)-0
`
`N‘)Ix)!-'l\)cD@\lI-‘P-‘Db-DP-it-Or-I!-lb-3!-‘Us>-0D-'>-‘(Ah-lf\)D-0P-VI\.).I.\F-‘OK?-‘IND5'-‘r>-‘V8IN)0}
`
`
`
`
`
`11/22/95
`
`U9/19/65
`12/20/82
`06/30/92
`12/17/90
`
`ISO
`
`UNK
`600
`600
`UNK
`
`*4 .579MG - 18.16MB
`
`0.01lMU - O.lMB
`0.02MG - 0.53MB
`1.0%
`5.02
`
`id/ii/90
`
`U1/1U/91
`
`600
`
`600
`
`n any
`
`2.12
`
`05/28/93
`
`600
`
`.012 - 0.0252
`
`10/20/95
`
`UNK
`
`0.01% - 0.02%
`
`09/29/95
`09/13/95
`O1/16/B5
`03/28/73
`
`04/11/14
`
`600
`600
`600
`$00
`
`600
`
`0.000042 - 10.0%
`0.0012 ~ 0.0252
`0.012 — 0.022
`0.12
`
`0.012
`
`|nnoPharma Exhibit 10800013
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`INSERT, CONTROLLED RELEASE
`
`INJECTION
`
`ASPARTAME
`ORAL! TABLET (IMMED./COMP. RELEASE), UNCOATEO,
`ASPARTIC ACID
`IV(INFUSION);
`BALSAM CANADA
`TOPICAL; LOTION
`BALSAM, 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
`BEESHAX, SYNTHETIC
`TOPICAL; EMULSION, CREAM
`BENTONITE
`ORAL; CAPSULE
`ORAL; SUSPENSION
`ORAL; TABLET
`TOPICAL; SUSPENSION, SHAMPOO
`TRANSDERMAL; 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
`- NASAL1 SPRAY
`NASAL; SPRAY, METERED
`0PHTHALMIC:.GEL
`OPHTHALMIC; OINTMENT
`OPHTHALMIC; SOLUTION
`OPHTHALMIC; SUSPENSION
`OTIC; SOLUTION
`TOPICAL; LOTION
`TOPICAL; SHAMPOO
`TOPICAL; SOLUTION
`
`CA5 #
`
`053906697
`
`000056848
`
`008007474
`
`007727437
`
`001302789
`
`000100527
`
`008001545
`
`PAGE 8
`
`*
`
`IH
`
`
`
`

`

`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`CA5 it
`
`mm ~ LAST
`COUNT
`NBA
`
`APPROVAL
`DATE
`
`mv
`
`POTENCY RANGE
`
`INJECTION
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`BENZENESULFONIC ACID SOLUTION
`INTRAVENOUS;
`INJECTION
`INTRAVENOUS; SOLUTION,
`IV(INFUSION);
`INJECTION
`BENZETNONIUM CHLORIDE
`IM - IV;
`INJECTION
`INTRAMUSCULAR1 INJECTION
`INTRAVENOUS; POHDER, FOR INJECTION SOLUTION
`IV(INFUSION);
`INJECTION
`NASAL; SPRAY, METERED
`OPHTHALMIC; POWDER, FOR RECONSTITUTION
`OPHTHALMIC; SOLUTION
`OTIC; 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
`EPIDURAL1 INJECTION
`IM - IV - SC;
`INJECTION
`IN -
`IV} INJECTION
`IN - IV; POWDER, FOR INJECTION SOLUTION
`IM ‘
`IV; SOLUTION,
`INJECTION
`IM - SC:
`INJECTION
`IM1- SC;
`INJECTION; SUSTAINED ACTION
`INTERSTITIAL;
`INJECTION
`INTRA-ARTERIAL;
`INJECTION
`INTRA-ARTICULAR;
`INJECTION
`INTRABURSALfi
`INJECTION
`INTRACAVITARY;
`INJECTION
`INTRACAVITARY; POHDER, FOR INJECTION SOLUTION, LYOPHILI
`
`‘
`
`
`
`III
`
`000121540
`
`00728104}
`
`000065850
`
`009000059
`
`000100516
`
`'
`
`1
`
`PA
`
`GE 9
`
`W3
`
`
`
`9
`
`1
`
`
`
`
`
`N>—*>-'U'I.Dv-It-'f\)U1DJU\UJ\OP~‘9-4)-JD-I.bI\)|—l.D\>-'®UJ.h®|-3)-'-*7-*.C.‘bdON!-‘P-‘P-'D-JD--4)-d&D-ll-It-'
`
`07/16/81
`
`600
`
`0.01%
`
`10/31/94
`
`600
`
`0.022
`
`01/29/93
`
`600
`
`0.2% - 5.0%
`
`04/24/91
`10/10/86
`08/28/81
`01/17/39
`
`120
`600
`110
`600
`
`D9/15/95
`
`UNK
`
`uu/go/ya
`01/04/95
`
`szu
`600
`
`BOOK?
`
`12':
`
`uwnuwNNNN
`
`\‘ \'
`
`0.1% - 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
`
`0.9% - 1.52
`0.0012 - 15.0%
`16.4MG ~ 66.9MG
`0.0722 — 0.9452
`0.9% - 2.2%
`1.2%
`
`04/09/86
`02/13/74
`
`600
`600
`
`0.001% - 1.0%
`0.9%
`
`|nnoPharma Exhibit 1080.0014
`
`

`

`
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`'
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED 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
`
`0.92
`0.92 - 1.02
`0.0012 - 10.452
`
`0.92
`0.452 - 0.92
`0.452 - 0.92
`0.0012 - 3.02
`
`0.92 - 2.022
`0.92 - 1.52
`0.752 - 3.02
`
`12/20/95
`
`520
`
`Ul5/UZ/U5-
`
`UNK
`
`I.231MG
`
`01/05/89
`06/19/95
`
`Ub/Z9/HZ
`
`uz/In/an
`
`uv/zu/9:
`12/07/92
`10/09/85
`
`I10
`570
`
`bUU
`
`OUU
`
`UNK
`UNK
`600
`
`0.49MB - 1.06MG
`O.9fiMG ~ 2.31MG
`
`0.0012 - 0.92
`0.72
`
`0.22 - 2.22
`0.72 ~ 1.02
`
`12/04/95
`
`600
`
`1.02
`
`07/30/81
`
`600
`
`0.012 ~ 46.02
`
`|nnoPharma Exhibit 10800015
`
`28
`
`77
`
`2III
`
`I1
`
`220
`
`14
`
`Ox
`
`17
`57
`
`51I
`
`36
`
`191113214141
`
`30
`
`9311161 8 1
`
`’_ BENZYL ALCOHOL
`INJECTION
`INTRAOERMAL;
`INTRALESIONAL;
`INJECTION
`INTRAMUSCULAR;
`INJECTION
`INTRAMUSCULAR; POWDER, FOR INJECTION SOLUTION
`INTRAMUSCULAR; SOLUTION,
`INJECTION
`INTRAPERITONEAL;
`INJECTION
`INTRAPLEURAL;
`INJECTION
`INTRASYNOVIAL;
`INJECTION
`INTRATHECAL;
`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; NOR 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
`
`HI
`
`000100516
`
`000120514
`
`000100447
`
`PAGE 10
`
`

`

`
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`CAS 3
`ND A
`COUNT
`
`LAST
`NBA
`
`APPROVAL
`DATE
`
`DIV
`
`POTENCY RANGE
`
`.052 - 2.02
`.62 - 1.02
`
`00
`
`01/13/76
`
`600
`
`00/02/63
`12/29/95
`12/28/82
`02/25/94
`
`UNK
`600
`600
`600
`
`11/26/82
`
`600
`
`08/08/85
`
`E10
`
`.flO03Z
`
`11/22/95
`
`150
`
`.1MG -
`
`fl.2MG
`
`.D4MG - n.sMn
`
`.1uz:nu - 0.213HG
`.5MG
`.0O5ZZ
`.00SZ - 0.02%
`
`nn172 - 0.00442
`
`Q 3O
`
`CDDC
`
`.0MG
`
`10/31/91
`
`08/31/92
`04/16/81
`12/23/82
`09/30/83
`04/26/93
`01/04/96
`
`U4/Z6/95
`
`600
`
`600
`600
`UNK
`UNK
`520
`snn
`
`520
`
`08/08/85
`
`510
`
`.0012
`
`|nnoPharma Exhibit 10800016
`
`INJECTION
`
`BETA-NAPHTHOL
`ORAL; CAPSULE
`BORIC ACID
`INJECTION
`INTRAVENOUS; SOLUTION,
`OPHTHALMIC; POWDER, FOR RECONSTITUTION
`OPHTHALMIC; SOLUTION
`OPHTHALMIC; SUSPENSION
`OTICJ SOLUTION
`TOPICAL; SHAMPOO
`BUFFER, ACETIC ACID-SODIUM ACETATE
`IN - IV - SC;
`INJECTION
`INTRA-ARTICULAR;
`INJECTION
`INTRAMUSCULAR;
`INJECTION
`INTRASYNOVIAL;
`INJECTION
`IV(INFUSION);
`INJECTION
`BUFFER, CITRIC ACID-SODIUM CITRATE
`IH -
`IV;
`INJECTION
`IV(INFUSION)z 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
`SUTYLATED NYDROXYTOLUENE
`INHALATION; LIQUID
`INTRAMUSCULAR;
`INJECTION
`IV(INFUSION);
`INJECTION
`NASAL; SPRAY, METERED
`
`
`
`‘H
`
`000135193
`
`010043353
`
`000106978
`
`000075650
`
`008003245
`
`000128370
`
`PAGE 11
`
`
`
`
`
`04NANA»NramhLDhH0¢ram»M~N»U~NhINwnawwuww»noHh*HBHNUHJWN
`
`

`

`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`BUTYLATED HYDROXYTOLUENE
`ORAL; CAPSULE
`ORAL; CAPSULE, SOFT GELATIN
`ORAL; TABLET
`ORAL; TABLET, SUSTAINED ACTION
`RECTAL; surrosxroav
`TOPICAL: EMULSION, AEROSOL FOAM
`TOPICAL; snunszon, casan
`TOPICAL: GEL
`TOPICAL; OINTMENT
`TOPICAL: soaurxon
`VAGINAL; EMULSION, caenn
`VASINAL; surrosxroav
`BUTYLENE GLYCOL
`TRANSDERMAL; FILM, CONTROLLED RELEASE
`BUTYLPARABEN
`INTRAMUSCULAR; znascrzon
`ORAL; CAPSULE
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; naops
`ORAL; SOLUTION
`ORAL; susrenszou
`ORAL; svnur
`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
`INJECTION
`IN - IV;
`INTRAMUSCULAR;
`INJECTION
`CALCIUM ACETATE
`' ORAL-21; TABLET
`ORAL-28; TABLET
`TOPICAL; EMULSION, CREAM
`CALCIUM ASCORBATE
`ORAL; SUSPENSION
`CALCIUM CARBONATE, PRECIPITATED
`ORAL; CAPSULE
`ORAL: CAPSULE, HARD GELATIN
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; TABLET
`
`’
`
`A
`
`CAS 3
`
`ooe12a37o
`
`NDA
`COUNT
`
`LAST
`NBA
`
`APPROVAL
`DATE
`
`DIV
`
`POTENCY RANGE
`
`NN>HdNrdcumoawhow¢Aw$>%hNw»u»nHhnbmhdHr»HhM0N\nuA»qnwN
`
`W
`
`003167830
`
`000094263
`
`,
`
`000058082
`
`007440702
`
`000062544
`
`005743271
`
`000471341
`
`PAGE 12
`
`an/17/7n
`
`12/11/87
`
`:10
`
`600
`
`n OIAMG —
`
`n 7MG
`
`O.1MG ~
`
`fl.OMG
`
`bUU U.UIZbMG ’ UTZ1éNG
`U5/31/92
`UNR
`11/(U/3d
`.uzz — 0.1%
`.052
`10/05/78 UNK
`.022
`O6/15/77
`UNK
`.nnz
`05/O4/77
`UNK
`
`DDGCZ
`
`12/20/95
`92/14/94
`
`520
`500
`
`U9/Z5/TA S20
`
`0.00582
`
`09/17/69
`03/31/81
`11/14/94
`
`aw/zv/an
`12/17/81
`12/23/83
`
`120
`UNK
`UNK
`
`DUO
`600
`600
`
`0.0028MG ~ U.00QMG
`0.006MG
`n.naMn
`
`u.zz - 8.4%
`0.02%
`0.18% - 0.3%
`
`04/12/88 600
`02/09/89
`600
`09/28/92
`600
`
`8.0MG - 8.3MG
`B.3MG - 10.0MG
`
`12/31/93 510
`
`125.6BMG - 224.7MG
`
`04/16/91
`
`600
`
`4.17MB - 60.0MG
`
`|nnoPharma Exhibit 1080.001?
`
`

`

`
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`CA5 #
`
`NBA
`COUNT
`
`LAST
`NBA
`
`APPROVAL
`DATE
`
`DIV
`
`POTENCY RANGE
`
`02/25/92
`
`600
`
`0.72MG - 64.8MG
`
`O8/19/91
`
`UNK
`
`87.5MG - 229.7MG
`
`02/25/94
`
`600
`
`0.382%
`
`12/01/86
`05/07/83
`
`600
`snn
`
`UQ/Z8/95
`
`600
`
`15/U1/no
`a9/22/93
`an/27/as
`
`ouu
`UNK
`§*,"?
`
`.O33Z
`O05?
`
`DD
`0.0QRZ
`
`u.U£4Z - 0.0332
`
`0.008Z
`
`11/18/93
`91/15/70
`O3/1%/7R
`
`12/30/81
`12/30/81
`
`2I.SMG - 16O.OMG
`
`‘7 ‘MG - 362.0MG
`
`82.9MG - 86.0MG
`B6.0MG
`I
`
`04/10/84
`04/18/62
`
`600
`I20
`
`I.8MG - Z.4MG
`S.OMG - 234.04MG
`
`11/30/95
`
`1C/(U/HZ
`
`6OO
`
`bUU
`
`n nzxma — n5g_gHg
`
`55.0MG - 168.0MG
`
`|nnoPharma Exhibit 1080.0018
`
`18
`
`I13II2 I3SI2I6221I 1 11 I I334122 1 221141
`
`2
`
`22
`
`ID
`
`I1
`
`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;
`EPIOURAL;
`INJECTION
`IM - IV;
`INJECTION
`INTRAMUSCULAR;
`INJECTION
`INTRAOCULAR; SOLUTION
`INTRAPERITONEAL; SOLUTION
`NERVE BLOCK;
`INJECTION
`OPHTHALMIC; PONDER, FOR RECONSTITUTION
`OQAL5 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 OIBASIC DIHYDRATE-SUCROSE AGGLDMERATE
`. ORAL; TABLET
`CALCIUM PHOSPHATE, DIBASIC
`ORAL; CAPSULE
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; PASTILLE
`ORAL: SYRUP
`I
`ORAL: TABLET
`ORAL; TABLET (IMMED./COMP. RELEASE), UHCOATED;
`ORAL; TABLET, COATED
`ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
`ORAL; TABLET, DISPERSIBLE
`
`000471341
`
`010035048
`
`O17140602
`
`001305620
`
`O0O814802
`
`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, SUSTAI