DEPARTMENT OF HEALTH & HUMAN SERVICES Jul 2 2 ings
`
`Public Health Service
`
`FOI SERVICES INC
`11 FIRSTFIELD RD
`GAITHERSBURG, MD 20878-1703
`
`Food and Drug Administration
`Rockville MD 20867
`
`06/09/98
`
`In reply refer to:
`98003174
`
`Your reference:
`152886
`
`Dear Requester:
`
`This is in response to your request for record(s) from the
`Food and Drug Administration pursuant to the Freedom of
`Information Act regarding:
`
`INACTIVE INGREDIENT GUIDE 1997
`
`Enclosed is (are) the requested record(s).
`
`The following charges for this request to date may be included
`in a monthly invoice:
`
`Reproduction (cid:9)
`
`Search (cid:9)
`
`Review Postage (cid:9)
`
`$3.50 (cid:9)
`
`$0.00 (cid:9)
`
`$0.00 (cid:9)
`
`Other (cid:9)
`
`$0.00
`
`Total
`
`The above total may not reflect final charges for this request.
`Please do not send payment unless you receive an invoice.
`
`All communications concerning this request should be identified
`with the reference number above and addressed as follows:
`
`Food and Drug Administration
`Freedom of Information Staff, HFI-35
`5600 Fishers Lane
`Rockville, MD 20857
`
`Sincerely yours,
`40iitemIAlas.
`MARY L. SEJAS
`LEAD INFORMATION TECHNICIAN
`
`(301)827-6563
`
`Enclosures:
`if indicated
`
`Exhibit 1025
`ARGENTUM
`IPR2018-00080
`
`000001
`
`(cid:9)
`

`

`foi FO! Services, inc.
`
`11 Firslifeld Road
`Gaithersburg MD 20878-1703 LISA
`Phone: 301-975-9400
`Fax: (cid:9)
`301-975-0702
`
`FOOD & DRUG ADMINISTRATION
`FREEDOM OF INFORMATION STAFF
`5600 FISHERS LANE
`ROCKVILLE, MD 20857
`
`1/30/98
`
`CONTROL NUMBER 152886
`
`PURSUANT TO THE PROVISIONS OF THE FREEDOM OF INFORMATION ACT, PLEASE
`PROVIDE US WITH A PAPER COPY (PREFERABLY NOT MICROFICHE) OF THE
`FOLLOWING DOCUMENTS. IF THE COST OF PROVIDING THESE DOCUMENTS WILL
`EXCEED 100.00, PLEASE CALL US FIRST FOR AUTHORIZATION OF THE CHARGES,
`UNLESS INDICATED OTHERWISE BELOW.
`
`PLEASE REFER TO OUR CONTROL NUMBER IN YOUR REPLY.
`
`COPY OF THE 1997 INACTIVE INGREDIENT GUIDE.
`
`F 3 3 -- 1C98
`
`CONTFORM4 5/95
`
`000002
`
`

`

`INACTIVE
`INGREDIENT GUIDE
`
`173
`
`O
`
`••••% •
`.41.•
`
`DIVISION OF
`DRUG INFORMATION RESOURCES
`
`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION'AND RESEARCH
`OFFICE OF MANAGEMENT
`
`JANUARY 1996
`
`- OFFICIAL USE OIVLY
`
`000003
`
`

`

`INACTIVE INGREDIENT GUIDE
`
`Purpose The Inactive Ingredient Guide contains all inactive ingredients present in approved drug products or conditionally
`approved drug products currently marketed for human use. The Guide is compiled by the Division of Drug Information
`Resources (DDIR). It provides CDER/CBER Reviewers with information on inactive ingredients in products which have been
`approved by the Agency Once an inactive ingredient appears in a currently approved drug product for a particular route of
`administration, the inactive ingredient would not usually be considered new and may require a less extensive review.
`
`Design The Inactive Ingredient Guide has been sorted first alphabetically by ingredient, and then by route of administration
`and dosage form Routes of administration and dosage forms are derived from current approved labeling.
`
`21. CFR 210.31b)18,7, respectively) defines inactive ingredients and active ingredients as follows: "Inactive
`Definitions (cid:9)
`ingredient means any component other than the active ingredient. Active ingredient means any component that is intended
`to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease,
`or to affect the structure or any function of the body of man or animals. The term (active ingredient) includes those
`components that may undergo chemical change in the manufacture of the drug product and be present in the finished drug
`product in a modified form intended to furnish the specified activity or effect." As an exception of the CFR definition, inactive
`ingredients listed in the Guide include only those which are present in the final dosage form of the drug product.
`
`Synonyms DDIR maintains a dictionary of all ingredients contained in submissions to CDER. Since many ingredients have
`synonyms (which do not appear in the Inactive Ingredient Guide), it may assist you to contact your Drug Information Officer
`if you cannot find a particular inactive ingredient.
`
`Proprietary Inactive Ingredients (cid:9) DDIR does not always include the components of proprietary inactive ingredients (e.g.,
`OPACODES). In such situations where components of proprietary inactive ingredients are included, you may have to search
`for such data under individual component entries.
`
`Warnings The Inactive Ingredient Guide lists inactive ingredients specifically intended as such by the manufacturer, Some
`of these inactive ingredients could also be considered as active ingredients under different circumstances (see 21 CFR
`210.30)117,311. Furthermore, reactants in radiopharmaceutical kits, or inactive ingredients which physically or chemically
`combine with active ingredients to facilitate drug trcinsport are considered 'as inactive ingredients for the purposes of this Guide.
`
`lContinuedl
`
`000004
`
`

`

`Contaminants The Inactive Ingredient Guide does not represent contaminants found in approved drug products.
`
`Carcinogens and Teratogens If any of the inactive ingredients represented in the Inactive Ingredient Guide are proven to be
`carcinogenic, teratogenic, or embryotoxic, please notify DDIR immediately. DDIR will attempt to relay your concern to each
`medical 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 (CAS) numbers associated with them. These can
`be found in the column to the right of the inactive ingredient. CAS numbers may be helpful to CDER/CBER Reviewers when
`initiating coniputer•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 number serve to qualify the data presented. The 'NDA
`CT' reflects the total number of NDAs in which a particular inactive ingredient currently appears. The 'Last NDA' specifies
`which NDA was the most recent one to be approved by the Agency with this inactive ingredient. The 'APPROVAL 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 collapsed into percentage of the total product in order to
`integrate data
`
`Colors The Certification Brb.ich 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 Kvung Kim, DDIR Chemists, at 443-3910.
`
`Procedure for Obtaining Further Assistance The Division of Drug Information Resources can also provide you with more
`specialized searche,, )n the automated data base from which the Inactive Ingredient Guide is generated. For assistance in using
`the Guide, to scheu (cid:9)
`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.
`
`The information in the Inactive Ingredient Guide is not to be released verbally or in writing.
`Much of the information in this report is considered proprietary, and should, therefore, be
`treated as confidential.
`
`000005
`
`

`

`DIVISION OF DRUG INFORMATION RESOURCES
`
`DRUG INFORMATION OFFICERS
`
`Division of Cardio•Renal Drug Products, HFD-110 (cid:9)
`
` Diane Centeno•Deshields, R.Ph.
`
`Division of Neuropharmacological Drug Products, HFD•120
`
` Diane Centeno-Deshields, R.Ph.
`
`Division of Oncologic Drug Products, HFD-150 (cid:9)
`
` Sharon Brownewell
`
`Division of Medical Imaging, Surgical, and Dental Products, HFD-160 (cid:9)
`
` Herbert Thornton, R.Ph.
`
`Division of Anesthesic, Critical Care, and Addiction Drug Products, HFD-170 (cid:9)
`
` Mary Guilderson
`
`Division of Gastrointestinal and Coagulation Drug Products, HFD•180
`
`Division of Metabolism and Endocrine Drug Products, HFD-510 (cid:9)
`
`Division of Anti-Infective Drug Products, HFD-520
`
`Division of Antiviral Drug Products, HFD-530
`
` Richard Lipov, R.Ph
`
` Ronald Brown, R.Ph.
`
` Mark W. Askine, R.Ph.
`
` Lee Anne Parsons
`
`Division of Dermatologic and Ophthalmologic Drug Products, HFD-540
`
` Mark W. Askine, R.Ph
`
`Division of Anti-Inflammatory, Analgesic, and Dental Drug Products, HFD-550 (cid:9)
`
` Mary Guilderson
`
`Division of Pulmonary Drug Products, HFD-570
`
`Division of Generic Drugs, HFD-600 (cid:9)
`
` Sharon Brownewell
`
`Janet Anderson, R.Ph.
`
`All DDIR Drug Information Of firers can be contacted at 443.0500 and cite located in Room 218 of the Chapman Building.
`
`000006
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`INACTIVE INGREDIENT FIELD DESCRIPTION
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`CAS#
`
`Ingredient Chemical substance added to enhance formulation of given
`dosage forms. Component of product other than active ingredient.
`
`ACACIA
`BUCCAL/SUBLINGUAL; TABLET
`ORAL: CAPSULE
`ORAL: CAPSULE, SUSTAINED ACTION
`ORAL: POWDER
`
`009000015 (cid:9)
`
`Route/Dosage Form Formulation intended for the specified route of
`administration or site of application.
`
`CAS# Registry number assigned to a compound by Chemical Abstracts
`Service on a random basis.
`
`NDA
`COUNT
`
`2
`1
`1
`1
`
`LAST
`NDA
`
`N05125
`N85296
`N17078
`N16640
`
`APPROVAL
`DATE
`
`02/02/77
`04/01/77
`08/02/76
`08/03/73
`
`DIVISION
`600
`600
`120
`510
`
`POTENCY
`RANGE
`4.0 • 9 1 MG
`
`0.01 • 0 7 MG
`21.0%
`
`NDA Count (cid:9) Reflects total number of approved NDAs in which a parti•
`particular inactive ingredient currently appears.
`
`Last NDA (cid:9) Specifies which NDA was the most recent one to be
`approved by the Agency with this active ingredient.
`
`Approval Date and DR/ (cid:9) Specifics the approval date and the Review
`Division responsible for evaluating this most recent NDA.
`
`Potency Range (cid:9)
`Specifies the minimum and maximum amounts of
`inactive ingredients for each route/dosage form.
`
`000007
`
`(cid:9)
`

`

`mx*xxx*xxxx*xxxxxxxxxxxxxxxxxxxx*xxxx
`FOR OFFICIAL USE ONLY
`3( (cid:9)
`MAY CONTAIN TRADE SECRET DATA (cid:9)
`x
`**moommi(m*****xxmoomomoomxxxX*
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`ACACIA
`BUCCAL/SUBLINGUAL; (cid:9) TABLET
`ORAL; CAPSULE
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; POWDER
`ORAL; POWDER, FOR RECONSTITUTION
`ORAL; SYRUP
`ORAL; TABLET
`ORAL; TABLET (IMMED./COMP. (cid:9) RELEASE), UNCOATED,
`ORAL; TABLET, COATED
`ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
`ORAL; (cid:9) TABLET, (cid:9) FILM COATED
`ORAL; (cid:9) TABLET, (cid:9) REPEAT ACTION
`ORAL; TABLET, SUSTAINED ACTION
`ORAL-21; (cid:9) TABLET
`ORAL-28; (cid:9) TABLET
`ACACIA MUCILAGE
`ORAL; TABLET, COATED
`ACETIC ACID
`IM - (cid:9) IV - SC; (cid:9) INJECTION
`IM - SC; (cid:9) INJECTION
`INTRAMUSCULAR; (cid:9) INJECTION
`INTRAVENOUS; (cid:9) INJECTION
`IV(INFUSION); (cid:9) INJECTION
`OPHTHALMIC; POWDER, (cid:9) FOR RECONSTITUTION
`OPHTHALMIC; (cid:9) SOLUTION
`SUBCUTANEOUS; (cid:9) INJECTION
`TOPICAL; (cid:9) SOLUTION
`TOPICAL; (cid:9) SPONGE
`ACETIC ACID, GLACIAL
`IM - (cid:9) IV - SC; (cid:9) POWDER, (cid:9) FOR (cid:9) INJECTION SOLUTION
`IM - (cid:9) IV; (cid:9) INJECTION
`IM - (cid:9) IV; (cid:9) POWDER, (cid:9) FOR INJECTION SOLUTION
`IM - (cid:9) SC; (cid:9) INJECTION
`IM - SC; (cid:9) INJECTION, (cid:9) SUSTAINED ACTION
`INTRA-ARTICULAR; (cid:9) INJECTION
`INTRAMUSCULAR; (cid:9) INJECTION
`INTRASYNOVIAL; (cid:9) INJECTION
`INTRAVENOUS; (cid:9) INJECTION
`IRRIGATION; (cid:9) SOLUTION
`IV(INFUSION); (cid:9) INJECTION
`IV(INFUSION); (cid:9) POWDER, (cid:9) roR (cid:9) INJECTION SOLUTION
`IV(INFUSION); (cid:9) SOLUTION, (cid:9) INJECTION
`NASAL; (cid:9) SOLUTION
`NASAL; (cid:9) SPRAY, (cid:9) METERED
`OPHTHALMIC; (cid:9) SOLUTIOA
`ORAL; (cid:9) CAPSULE, (cid:9) HARD uLLAI1U
`
`CAS #
`
`009000015
`
`NDA (cid:9)
`COUNT (cid:9)
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV POTENCY RANGE
`
`1
`2
`1
`113
`2
`51
`1
`7
`2
`13
`2
`4
`
`1
`
`1
`1
`3
`10
`9
`1
`1
`1
`1
`1
`
`1
`5
`1
`7
`1
`3
`9
`3
`13
`1
`27
`1
`1
`1
`1
`1
`1
`
`008047389
`
`000064197
`
`PAGE 1
`
`03/0R/AR 600
`•
`09/29/95 600 0.03GM
`07/29/92 600 3.22MG - 80.0MG
`02/25/92 600 0.02M0 - 156.0MG
`
`U5/15/115 60U 0.04MG - 0.08MG
`03/31/81 UNK 11.542MG
`01/04/95 600 2.0MG - 34.4MG
`10/01/76 510 1.26MG
`03/29/76 510 1.26MG
`
`07/09/80 510
`07/31/90 600 0.046%
`03/25/94 160 0.027% - (cid:9) 0.44%
`
`05/07/88 600 0.135% (cid:9) - (cid:9) 0.25%
`
`04/14/95 6UU 0.01% (cid:9) - (cid:9) 0.48%
`
`U5/U///8 600
`05/02/88 600 V.006% (cid:9) - (cid:9) 0.0442%
`05/07/78 600
`03/17/94 UNK 0.01% - (cid:9) 0.225%
`
`IUM/95 510 0.12% (cid:9) - (cid:9) 0.435%
`
`000008
`
`

`

`xxxxx*xxxxxxxxxxxxxx*xxxxxxxxxxxxxxx*
`FOR OFFICIAL USE ONLY
`X (cid:9)
`MAY CONTAIN TRADE SECRET DATA (cid:9)
`*
`*************************************
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`ACETIC ACID, GLACIAL
`ORAL; CONCENTRATE
`ORAL; SOLUTION, ELIXIR
`OTIC; SOLUTION
`()TIC; SUSPENSION
`SUBCUTANEOUS; INJECTION
`ACETIC ANHYDRIDE
`ORAL; TABLET, SUSTAINED ACTION
`ACETONE SODIUM BISULFITE
`DENTAL; (cid:9) INJECTION
`INHALATION; (cid:9) SOLUTION
`NERVE BLOCK; (cid:9) INJECTION
`ACETYL TRIBUTYL CITRATE
`ORAL; CAPSULE, (cid:9) ENTERIC COATED PELLETS
`ORAL; CAPSULE, (cid:9) SUSTAINED ACTION
`ORAL; TABLET, ENTERIC COATED PARTICLES
`ORAL; TABLET, SUSTAINED ACTION
`ACETYLATED MONOGLYCERIDES
`INTRAVENOUS; (cid:9) INJECTION
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; TABLET
`ORAL; TABLET, COATED
`ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
`ORAL; (cid:9) TABLET, FILM COATED
`ORAL; (cid:9) TABLET, (cid:9) SUSTAINED ACTION
`ACETYLCYSTEINE
`INHALATION; (cid:9) SOLUTION
`ACRYLATES COPOLYMER
`TRANSDERMAL; (cid:9) FILM, (cid:9) CONTROLLED RELEASE
`ADCOTE 72A103
`TRANSDERMAL; FILM, CONTROLLED RELEASE
`AEROSIL 380
`ORAL; (cid:9) TABLET, DELAYED ACTION, (cid:9) ENTERIC COATED
`AEROSIL-200
`ORAL; TABLET
`ORAL; TABLET, FILM COATED
`AEROTEX RESIN 3730
`TRANSDERMAL; FILM, CONTROLLED RELEASE
`
`AIR
`
`INHALATION; (cid:9) GAS
`ALBUMIN AGGREGATED
`INTRAVENOUS; (cid:9) INJECTION
`ALBUMIN COLLOIDAL
`INTRAVENOUS; (cid:9) POWC[X, (cid:9) fOR (cid:9) INACTION SOLUTION
`
`CAS IE
`
`000064197
`
`000108247
`
`000540921
`
`000616911
`
`PAGE ?
`
`NDA (cid:9)
`COUNT (cid:9)
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV POTENCY RANGE
`
`2
`1
`1
`2
`2
`
`1
`
`1
`2
`3
`
`1
`1
`1
`2
`
`1
`1
`33
`2
`2
`10
`3
`
`4
`
`1
`
`1
`
`1
`
`20
`2
`
`1
`
`3
`
`5
`
`1
`
`12/16/85 600 0.075% - (cid:9) 0.1%
`
`11/06/85 600 0.36%
`06/12/91 510 0.2%
`
`
`06/30/81 600, 0.4% - 0.50034%
`11/15/79 600 0.1% (cid:9) - (cid:9) 0.2%
`
`01/10/92 110 2.0MG - (cid:9) 9.0MG
`
`uc/[i/91 600 0.04MG - 2.7MG
`04/26/78 600
`03/29/82 600 2.92MG - 5.17MG
`02/02/87 600 0.04MG - 2.1MG
`05/14/85 UNK
`
`11/22/88 600
`
`08/17/88 600 0.1MG (cid:9) - (cid:9) 9.0MG
`02/02/87 600 3.6MG - (cid:9) 7.2MG
`
`10/01/82 160
`
`12/30/87 160 0.025%
`
`000009
`
`

`

`xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
`FOR OFFICIAL USE ONLY
`x
`MAY CONTAIN TRADE SECRET DATA (cid:9)
`x (cid:9)
`xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`•
`•
`
`INGREDIENT (cid:9)
`ROUTE/DOSAGE FORM (cid:9)
`
`ALBUMIN HUMAN (cid:9)
`INTRAVENOUS; (cid:9) INJECTION
`INTRAVENOUS; POWDER, FOR INJECTION SOLUTION
`IV(INFUSION); (cid:9) INJECTION.
`ALCOHOL
`DENTAL; SOLUTION
`IM - (cid:9) IV; (cid:9) INJECTION
`IM - (cid:9) IV; (cid:9) SOLUTION, (cid:9) INJECTION
`INHALATION; AEROSOL, METERED
`INHALATION; SOLUTION
`INTRAMUSCULAR; (cid:9) INJECTION
`INTRAVENOUS; (cid:9) INJECTION
`IV - SC; (cid:9) INJECTION
`IV(INFUSION); (cid:9) INJECTION
`IV(INFUSION); (cid:9) SOLUTION, (cid:9) INJECTION
`OPHTHALMIC; (cid:9) SOLUTION
`ORAL; AEROSOL SPRAY
`ORAL; (cid:9) CONCENTRATE
`ORAL; (cid:9) SOLUTION
`ORAL; (cid:9) SOLUTION, (cid:9) ELIXIR
`ORAL; (cid:9) SUSPENSION
`ORAL; SYRUP
`RECTAL; (cid:9) SUSPENSION
`TOPICAL; AEROSOL SPRAY
`TOPICAL; GEL
`TOPICAL; (cid:9) LOTION
`TOPICAL; (cid:9) SOLUTION
`TRANSDERMAL; FILM, CONTROLLED RELEASE
`VAGINAL; (cid:9) EMULSION, CREAM
`ALCOHOL, DEHYDRATED
`IM - (cid:9) IV; (cid:9) INJECTION
`IM - (cid:9) IV; (cid:9) POWDER, (cid:9) FOR (cid:9) INJECTION SOLUTION
`INHALATION; (cid:9) AEROSOL, (cid:9) METERED
`INTRAMUSCULAR; (cid:9) INJECTION
`INTRAVASCULAR; (cid:9) INJECTION
`INTRAVENOUS; (cid:9) INJECTION
`IV(INFUSION); (cid:9) INJECTION
`IV(INFUSION); (cid:9) POWDER, (cid:9) FOR (cid:9) INJECTION SOLUTION
`IV(INFUSION); (cid:9) SOLUTION, (cid:9) INJECTION
`NASAL; AEROSOL SPRAY
`NASAL; (cid:9) AEROSOL, METERED
`OPHTHALMIC; (cid:9) SOLUTION
`ORAL; CONCENTRATE
`ORAL; (cid:9) SOLUTION
`ORAL; (cid:9) SOLUTION, (cid:9) ELIXIR
`ORAL; (cid:9) SUSPENSION
`ORAL; (cid:9) SYRUP
`
`CAS B (cid:9)
`
`009006535
`
`000064175
`
`000064175
`
`PAGE 3
`
`NDA (cid:9)
`COUNT (cid:9)
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV
`
`POTENCY RANGE
`
`9
`1
`1
`
`4
`21
`1
`5
`1
`1
`3
`1
`8
`2
`1
`1
`13
`28
`23
`18
`35
`2
`1
`2
`2
`15
`3
`1
`
`7
`1
`4
`2
`1
`6
`12
`1
`1
`1
`1
`2
`5
`5
`6
`8
`19
`
`12/28/90 510 0.05% (cid:9) - (cid:9) 1.2%
`
`12/28/95 600 10.0% (cid:9) - (cid:9) 12.15%
`01 /79/93 600 8.55% - (cid:9) 11.0%
`
`1Z/G8/84 uuj 511.114 (cid:9) - (cid:9) 38.0%
`
`07/10/94 600 6.8% - (cid:9) 30.5%
`
`U8/5U/95 600 0.61% (cid:9) - (cid:9) 52.9%
`12/31/86 110 10.0% (cid:9) - (cid:9) 30.0%
`
`08/30/91 600 0.019% (cid:9) - (cid:9) 71.6%
`11/17/95 530 0.23% (cid:9) - (cid:9) 30.0%
`04/29/93 600 5.0% (cid:9) - (cid:9) 20.4%
`09/15/95 180 0.0000067% (cid:9) - (cid:9) 7.25%
`10/28/94 600 0.5% (cid:9) - (cid:9) 7.5%
`11/17/86 600
`
`06/18/90 UNK 52.0%
`07/03/85 600 71.0% (cid:9) - (cid:9) 80.5%
`02/27/95 600 33.0% - 83.0%
`09/29/95 510
`
`10/13/87 600 0.01% (cid:9) - (cid:9) 10.0%
`
`U4/LS/8L UNK 1.0% (cid:9) - (cid:9) 34.548%
`)1/30/89 UNK 10.0%
`
`0//1//95 6Uu 5.0% (cid:9) - (cid:9) 50.0%
`08/30/95 600 10.0% (cid:9) - (cid:9) 80.0%
`
`10/11/88 600 0.5%
`11/30/94 600 0.00003% (cid:9) - (cid:9) 7.37%
`07/14/95 530 0.1% (cid:9) - (cid:9) 24.9%
`01/25/82 600 12.0% (cid:9) - (cid:9) 20.0%
`06/18/87 c
`0.26% (cid:9) - (cid:9) 1.0%
`11/22/85 auu 5.0% (cid:9) - (cid:9) 7.0%
`
`000010
`
`

`

`XXXXXXXXXXXX*XXXXXXXXXXXXAMXXXXXXXXXX
`FOR OFFICIAL USE ONLY
`
`MAY CONTAIN TRADE SECRET DATA (cid:9)
`*
`* (cid:9)
`mx)(xxxxxxxx*mxxxxxxicoomxxxxxxx*xxxxx
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`ALCOHOL, DEHYDRATED
`TOPICAL; GEL
`TOPICAL; SOLUTION
`TOPICAL; SWAB
`ALCOHOL, DENATURED
`DENTAL; GEL
`DENTAL; PASTE
`TOPICAL; AEROSOL
`TOPICAL; EMULSION, AEROSOL FOAM
`TOPICAL; GEL
`TOPICAL; SOLUTION
`TOPICAL; SWAB
`ALCOHOL, DILUTED
`IM - IV; (cid:9) INJECTION
`ORAL; (cid:9) SOLUTION
`ORAL; (cid:9) SOLUTION, (cid:9) ELIXIR
`ORAL; SUSPENSION
`ORAL; SYRUP
`TOPICAL; AEROSOL SPRAY
`TOPICAL; POWDER, FOR RECONSTITUTION
`ALOINIC ACID
`OPHTHALMIC; DRUG DELIVERY SYSTEM
`OPHTHALMIC; SUPPOSITORY, (cid:9) INSERT, CONTROLLED RELEASE
`ORAL; CAPSULE
`ORAL; TABLET
`ORAL; TABLET (IMMED./COMP. (cid:9) RELEASE), UNCOATED,
`ORAL; TABLET, COATED
`ORAL; TABLET, FILM COATED
`ORAL; (cid:9) TABLET, SUSTAINED ACTION
`ALKYL AMMONIUM SULFONIC ACID BETAINE
`TOPICAL; (cid:9) SPONGE
`ALKYL ARYL SODIUM SULFONATE
`TOPICAL; SUSPENSION, (cid:9) SHAMPOO
`ALLANTOIN
`TO?ICAL; GEL
`VAGINAL; EMULSION, CREAM
`A'.THEA
`ORAL; SUSPENSION
`ALUMINUM ACETATE
`OTIC; SOLUTION
`TOPICAL; EMULSION, CREAM
`TOPICAL; SHAMPOO
`ALUMINUM HYDROXIDE
`TOPICAL; EMULSION, CREAM
`TOPICAL; (cid:9) OINTMENT
`
`CAS 11
`
`000064175
`
`008024451
`
`008000166
`
`009005327
`
`000097596
`
`000139128.
`
`001302290
`
`PAGE
`
`NDA (cid:9)
`COUNT (cid:9)
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`•
`
`DIV POTENCY RANGE
`
`4
`5
`1
`
`1
`1
`1
`1
`3
`5
`2
`
`1
`1
`2
`1
`3
`1
`1
`
`1
`1
`2
`22
`3
`1
`3
`1
`
`1
`
`1
`
`I
`I
`
`1
`
`I
`I
`I
`
`4
`2
`
`01/29/93 600 20.0% - 94.7808%
`09/28/90
`600 55.0% - 77.0%
` .
`
`10/26/84 UNK 75.35% - 96.9385%
`01/11/91 600 44.0% - 60.16%
`07/30/93 600 75.0%
`
`us/16/79 600 6.5176%
`
`uurzifiu 600 U.5% (cid:9) - (cid:9) 1.5%
`
`u5/1.4/116 600 17.0MG
`12/29/94 110 0.07MG - 30.0MG
`06/78/89 6nn icn (cid:9) OM( (cid:9) - (cid:9) 400.0110
`
`U9/05/80 600 16.804MG - 52.8MG
`
`12/22/87 600 5.0%
`10/10/85 600
`
`000011
`
`

`

`********************xxxx*xxxx****xxxx
`*
`FOR OFFICIAL USE ONLY
`* MAY CONTAIN TRADE SECRET DATA
`)0000000000000000000000M0(100000000(
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`CAS * (cid:9)
`
`LAST (cid:9)
`NDA (cid:9)
`COUNT NDA (cid:9)
`
`APPROVAL
`DATE (cid:9)
`
`DIV POTENCY RANGE
`
`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, SUSTAINED 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
`ORAL; TABLET, FILM COATED
`AMERCHOL L101
`TOPICAL; EMULSION, CREAM
`AMERCHOL-CAB
`OPHTHALMIC; OINTMENT
`AMMONIA
`INHALATION; LIQUID
`AMMONIA SOLUTION
`ORAL; SUSPENSION
`
`1
`
`4 (cid:9)
`
`2 (cid:9)
`
`2 (cid:9)
`
`1
`
`1
`
`1
`
`1
`
`1
`1
`1
`
`1
`1
`3
`2
`
`2
`3
`
`1
`
`1
`9
`1
`1
`
`5
`
`2
`
`1
`
`1
`
`012040594
`
`008012633
`
`001344281
`
`012141467
`
`007047849
`
`010043013
`
`009002191
`
`008029047
`
`007664417
`
`008007576
`
`PAGE 5
`
`01/29/93 600 0.3X - 1.0%
`
`10/08/85 600 2.0%
`
`10/08/85 "600 3.0X
`
`10/29/93 UNK
`12/17/90 UNK
`
`02/25/94 600
`09/28/92 600
`
`12/21/90 600 1.0MG - 12.0MG
`
`08/25/89 UNK l.0% - 5.0X
`
`12/03/86 600
`
`000012
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`mx*xxxxxxxxmxxxxxwxx*mmx*xxxxxxxx*xxx
`FOR OFFICIAL USE ONLY
`* (cid:9)
`MAY CONTAIN TRADE SECRET DATA (cid:9)
`x
`XXXXIMMOIXXXXXX*MXIMMXXXXXX*10000000E
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`AMMONIUM ACETATE
`INTRAMUSCULAR; INJECTION
`INTRAVENOUS; INJECTION
`AMMONIUM CALCIUM ALGINATE
`ORAL; TABLET
`AMMONIUM CHLORIDE
`ORAL; TABLET
`AMMONIUM HYDROXIDE
`INTRAVENOUS; INJECTION
`ORAL; CAPSULE
`SUBCUTANEOUS; INJECTION
`AMMONIUM PHOSPHATE, DIBASIC
`ORAL; TABLET
`AMMONIUM SALT OF C-12-C-15 LINEAR PRIMARY ALCOHOL ETHOXYLATE
`TOPICAL; SPONGE
`AMMONIUM SULFATE
`IM - IV; POWDER, FOR INJECTION SOLUTION
`INTRAVENOUS; (cid:9) SUSPENSION, (cid:9) INJECTION
`IV(INFUSION); POWDER, FOR INJECTION SOLUTION
`AMMONYX
`TOPICAL; EMULSION, AEROSOL FOAM
`TOPICAL; SOLUTION
`TOPICAL; SPONGE
`AMPHOTERIC-2
`TOPICAL; SUSPENSION, SHAMPOO
`AMPHOTERIC-6
`TOPICAL; EMULSION, CREAM
`ANETHOLE
`DENTAL; SOLUTION
`ORAL; (cid:9) SOLUTION
`ORAL; (cid:9) SOLUTION, (cid:9) ELIXIR
`ANIDRISORB 85/70
`ORAL; CAPSULE, (cid:9) SOFT GELATIN
`ANISE EXTRACT
`ORAL; (cid:9) SOLUTION, (cid:9) ELIXIR
`ANISE OIL
`ORAL; (cid:9) PASTILLE
`ORAL; (cid:9) SOLUTION, (cid:9) ELIXIR
`ORAL; SUSPENSION
`ANISE, (cid:9) STAR
`ORAL; (cid:9) SOLUTION, (cid:9) ELIXIR
`ANOXID SIM
`TOPICAL; EMULSION, CREAM
`ANTIFOAM
`ORAL; (cid:9) SUSPENSION
`TOPICAL; (cid:9) LOTION
`
`CAS 8
`
`000631618
`
`012125029
`
`007783280
`
`007783202
`
`004180238
`
`000104461
`
`008007703
`
`008051089
`
`PAGE 6
`
`111
`
`NDA
`COUNT
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV POTENCY RANGE
`
`3
`3
`
`1
`
`6
`
`1
`4
`1
`
`3
`
`1
`
`1
`1
`1
`
`1
`1
`1
`
`1
`
`1
`
`1
`1
`5
`
`2
`
`2
`
`1
`2
`1
`
`1
`
`2
`
`1
`2
`
`i 01/27/95 600 0.4%
`. 01/27/95 600 0.4%
`
`; 06/09/87 .600 2.4MG - 4.2MG
`
` 05/16/95 600
`
`11/02/87 600 0.4MG
`
`10/03/83 600 0.003%
`
`04/20/95 UNK 30.045MG - (cid:9) 123.0MG
`
`03/26/76 600
`
`12/16/83 600
`
`10/31/94 600 0.15625%
`
`07/16/74 600 0.01% (cid:9) - (cid:9) 0.031%
`
`000013
`
`

`

`xxxxxxmxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
`X (cid:9)
`FOR OFFICIAL USE ONLY
`x
`K (cid:9)
`MAY CONTAIN TRADE SECRET DATA (cid:9)
`xxxxx*xxxx*xxxxxxx**xxxx*xxxmxxxxx*xx
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`CAS •
`
`NDA
`COUNT
`
`LAST (cid:9)
`NDA (cid:9)
`
`APPROVAL
`DATE
`
`DIV POTENCY RANGE
`
`ANTIFOAM DC
`ORAL; POWDER, FOR RECONSTITUTION
`ANTIPYRINE
`OPHTHALMIC; SOLUTION
`APUACOAT
`ORAL; TABLET (IMMED./COMP. (cid:9) RELEASE), (cid:9) UNCOATED,
`AQUACOAT ECD
`ORAL; TABLET, FILM COATED
`AqUAPHOR
`TOPICAL; EMULSION, CREAM
`TOPICAL; OINTMENT
`ARGININE
`IM - IV; INJECTION
`INTRAVENOUS; POWDER, FOR INJECTION SOLUTION
`IV(INFUSION); (cid:9) INJECTION
`ARLATONE 289
`TOPICAL; EMULSION, CREAM
`ASCORBIC ACID
`CAUDAL BLOCK; (cid:9) INJECTION
`EPIDURAL; (cid:9) INJECTION
`IM - (cid:9) IV; (cid:9) INJECTION
`INHALATION; AEROSOL, METERED
`INHALATION; (cid:9) SOLUTION
`INTRAMUSCULAR; (cid:9) INJECTION
`INTRAVENOUS; (cid:9) INJECTION
`INTRAVENOUS; POWDER, FOR INJECTION SOLUTION
`IV(INFUSION); (cid:9) INJECTION
`IV(INFUSION); POWDER, FOR INJECTION SOLUTION
`•
`NERVE BLOCK; (cid:9) INJECTION (cid:9)
`ORAL; CAPSULE
`ORAL; CONCENTRATE
`ORAL; SUSPENSION, SUSTAINED ACTION
`ORAL; SYRUP
`ORAL; TABLET
`ORAL; TABLET, (cid:9) FILM COATED
`RECTAL; SUPPOSITORY
`SUBCUTANEOUS; (cid:9) INJECTION
`ASCORBYL PALMITATE
`ORAL; CAPSULE
`ORAL; TABLET
`RECTAL; SUPPOSITORY
`TOPICAL; EMULSION, CREAM
`ASPARTAME
`ORAL; GRANULE, EFFFRVESCENT
`ORAL; POWDER
`ORAL; (cid:9) POWDER, (cid:9) FOR RECONSTITUTION
`ORAL; (cid:9) SYRUP
`
`000060800
`
`008029150
`
`000050817
`
`000137666
`
`053906697
`
`PAGE 7
`
`1
`
`1
`
`1
`
`2
`
`1
`1
`
`3
`1
`3
`
`1
`
`1
`2
`7
`11
`5
`6
`1
`3
`2
`1
`1
`5
`1
`2
`6
`1
`
`1
`
`1
`1
`
`5
`
`1
`2
`1
`
`10/03/90 600
`
`03/31/97 Ann
`
`11/0F/95 600 0.78% - (cid:9) 1.56%
`
`07/25/74 600 .0.2%
`12/28/84 UNK 0.1% - (cid:9) 0.24548%
`06/13/91 600 0.02% - (cid:9) 0.038%
`04/15/88 600 0.1% - (cid:9) 0.2%
`n3/09/n8 600
`
`02/16/159 buu
`10/27/83 600
`
`114/77/83 Ann 0.05% - (cid:9) 0.2%
`
`11/1b/15G 6UU
`08/29/88 600 1.0M0 - 28.44MG
`
`08/14/87 600
`
`12/23/91 520 0.10. 1.05%
`
`000014
`
`

`

`XXXXXXXXXXXXXXXXXXXXXXXXXXXXXSXXXXXXX
`FOR OFFICIAL USE ONLY
`MAY CONTAIN TRADE SECRET DATA (cid:9)
`K (cid:9)
`K
`XXXXXXXXXXWMIEMMXXXMOOMMKX*WMX1000(
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`ASPARTAME
`ORAL; TABLET (IMMED./COMP. RELEASE), (cid:9) UNCOATED,
`ASPARTIC ACID
`IV(INFUSION); (cid:9) INJECTION
`BALSAM CANADA
`TOPICAL; (cid:9) LOTION
`BALSAM, FIR
`TOPICAL; OIL
`BARIUM SULFATE
`INTRAUTERINE; SUPPOSITORY, (cid:9) INSERT, CONTROLLED RELEASE
`BEESWAX
`ORAL; CAPSULE, SOFT GELATIN
`ORAL; CAPSULE, (cid:9) SUSTAINED ACTION
`ORAL; TABLET
`ORAL; TABLET, COATED
`TOPICAL; EMULSION, CREAM
`TOPICAL; OINTMENT
`BEESWAX, SYNTHETIC
`TOPICAL; EMULSION, CREAM
`BENTONITE
`ORAL; CAPSULE
`ORAL; (cid:9) SUSPENSION
`ORAL; TABLET
`TOPICAL; (cid:9) SUSPENSION, (cid:9) SHAMPOO
`TRANSDERMAL; FILM, CONTROLLED RELEASE
`VAGINAL; (cid:9) SUPPOSITORY
`BENZALDEHYDE
`ORAL; SUSPENSION
`BENZALKONIUM CHLORIDE
`INHALATION; (cid:9) SOLUTION
`INTRA-ARTICULAR; (cid:9) INJECTION
`INTRABURSAL; (cid:9) INJECTION
`INTRADERMAL; (cid:9) INJECTION
`INTRALESIONAL; (cid:9) INJECTION
`INTRAMUSCULAR; (cid:9) INJECTION
`NASAL; SOLUTION
`NASAL; SPRAY
`NASAL; (cid:9) SPRAY, METERED
`OPHTHALMIC; GEL
`OPHTHALMIC; OINTMENT
`OPHTHALMIC; (cid:9) SOLUTION
`OPHTHALMIC; SUSPENSION
`OTIC; (cid:9) SOLUTION
`TOPICAL; (cid:9) LOTION
`TOPICAL; (cid:9) SHAMPOO
`TOPICAL; (cid:9) SOLUTION
`
`CAS N
`
`053906697
`
`000056848
`
`008007474
`
`007727437
`
`001302789
`
`000100527
`
`008001545
`
`PAGE 8
`
`NDA (cid:9)
`COUNT (cid:9)
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV POTENCY RANGE
`
`3
`
`2
`
`1
`
`1
`
`1
`
`2
`1
`16
`11
`4
`2
`
`1
`
`1
`2
`1
`3
`1
`1
`
`1
`
`6
`1
`1
`1
`1
`1
`1
`1
`10
`1
`1
`77
`28
`4
`2
`1
`2
`
`11/16/94 UNK 5.41MG - 40.0MG
`
`02/18/94 180 0.4% - (cid:9) 0.68X
`
`11/22/95 150 7.579MG - (cid:9) 15.16MG
`
`UV/IV/UV UNK U.UI/MU - (cid:9) 0.1MG
`12/20/82 600 0.02MG - C.53M0
`06/30/92 600 1.0X
`12/17/90 UNK 5.0X
`
`10/17/90 600
`
`n 6cY
`
`01/10/9'1 600 2.1%
`
`05/28/93 600 0.01% (cid:9) - (cid:9) 0.025%
`
`10/20/95 UNK 0.01% (cid:9) - (cid:9) 0.02%
`
`09/29/95 600 0.00004% (cid:9) - (cid:9) 10.0%
`09/13/95 600 0.001% (cid:9) - (cid:9) 0.025%
`01/16/85 600 0.01% (cid:9) - (cid:9) 0.02%
`03 /78/73 6nn 0.1%
`
`04/11//4 600 0.01%
`
`000015
`
`

`

`xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
`*
`FOR OFFICIAL USE ONLY (cid:9)
`x (cid:9)
`*
`MAY CONTAIN TRADE SECRET DATA (cid:9)
`MAIMEM1000(*XXXXXXIMMMMEXXXX*XXX
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`CAS I
`
`NDA (cid:9)
`COUNT (cid:9)
`
`LAST
`NDA
`
`APPROVAL
`DATE
`
`DIV POTENCY RANGE
`
`BENZENESULFONIC ACID MOTION
`INTRAVENOUS; (cid:9) INJECTION
`INTRAVENOUS; (cid:9) SOLUTION, (cid:9) INJECTION
`IV(INFUSION); (cid:9) INJECTION
`BENZETHONIUM CHLORIDE
`IM - IV; (cid:9) INJECTION
`INTRAMUSCULAR; (cid:9) INJECTION
`INTRAVENOUS; POWDER, FOR INJECTION SOLUTION
`IV(INFUSION); (cid:9) INJECTION
`NASAL; SPRAY, METERED
`OPHTHALMIC; POWDER, (cid:9) FOR RECONSTITUTION
`OPHTHALMIC; SOLUTION
`OTIC; SOLUTION
`BENZODODECINIUM BROMIDE
`OPHTHALMIC; SOLUTION
`BENZOIC ACID
`IM - (cid:9) IV; (cid:9) INJECTION
`INTRAMUSCULAR; (cid:9) INJECTION
`IRRIGATION; (cid:9) SOLUTION
`IV(INFUSION); (cid:9) INJECTION
`ORAL; SOLUTION
`ORAL; (cid:9) SOLUTION, (cid:9) ELIXIR
`ORAL; SUSPENSION
`ORAL; SYRUP
`ORAL; TABLET, COATED
`TOPICAL• (cid:9) EMULSION, (cid:9) CREAM
`TOPICAL; (cid:9) LOTION
`TOPICAL; (cid:9) SUPPOSITORY
`VAGINAL; EMULSION, CREAM
`VAGINAL; (cid:9) SUPPOSITORY
`BENZOIN
`ORAL; CAPSULE
`ORAL; CAPSULE, (cid:9) SUSTAINED ACTION
`BENZYL ALCOHOL
`EPIDURAL; (cid:9) INJECTION
`IM - (cid:9) IV - SC; (cid:9) INJECTION
`IM - (cid:9) IV; (cid:9) INJECTION
`IM - IV; POWDER, (cid:9) FOR INJECTION SOLUTION
`IM - IV; (cid:9) SOLUTION, (cid:9) INJECTION
`IM - SC; (cid:9) INJECTION
`IM - SC; (cid:9) INJECTION, (cid:9) SUSTAINED ACTION
`INTERSTITIAL; (cid:9) INJECTION
`INTRA-ARTERIAL; (cid:9) INJECTION
`INTRA-ARTICULAR; (cid:9) INJECTION
`INTRABURSAL; (cid:9) INJECTION
`INTRACAVITARY; (cid:9) INJECTION
`INTRACAVITARY; (cid:9) POWDER, (cid:9) FOR (cid:9) INJECTION SOLUTION, LYOPUIII
`
`000121540
`
`007281041
`
`000065850
`
`009000059
`
`000100516
`
`PAGE 9
`
`1
`1
`1
`
`8
`1
`1
`1
`1
`1
`1
`6
`
`1
`
`14
`1
`1
`1
`8
`4
`3
`8
`1
`4
`1
`2
`4
`1
`
`1
`1
`
`1
`9
`93
`5
`3
`15
`2
`1
`1
`24
`5
`1
`1
`
`07/16/81 600 0.01%
`
`10/31/94 600 0.02%
`
`01/29/93 600 0.2% (cid:9) - (cid:9) 5.0%
`
`04/24/91 120 0.1%
`10/10/86 600 0,1%
`08/28/81 110 0.1%
`0 (cid:9) 1%
`01/17/89 Ann
`
`09/15/95 UNK U.7%
`
`U%/[6/95 b4U
`01/04/95 600 0.1% (cid:9) - (cid:9) 0.2%
`
`12/29/93 600 0.9% (cid:9) - (cid:9) 1.5%
`06/30/94 600 0.001% (cid:9) • (cid:9) 15.0%
`03/19/82 600 16.4MG - (cid:9) 66.9MG
`03/05/90 600 0.472% (cid:9) - (cid:9) 0.945%
`07/25/83 600 0.9% (cid:9) - (cid:9) 2.2%
`07/14/87 600 1.2%
`
`04/09/06 600 C.001% (cid:9) - (cid:9) 1.0%
`62/13/74 600 0.9%
`
`000016
`
`

`

`mmmxxxxxximmmmmmxxxxxxxxxxmmmmumm
`K
`FOR OFFICIAL USE ONLY
`* MAY CONTAIN TRADE SECRET DATA *
`mmmmxmommmmmmmmmxxxxmwm***mmmmxxxm
`
`INACTIVE INGREDIENTS FOR CURRENTLY MARKETED DRUG PRODUCTS
`
`INGREDIENT
`ROUTE/DOSAGE FORM
`
`BENZYL ALCOHOL
`INTRADERMAL; INJECTION
`INTRALESIONAL; INJECTION
`INTRAMUSCULAR; INJECTION
`INTRAMUSCULAR; POWDER, FOR INJECTION SOLUTION
`INTRAMUSCULAR; SOLUTION, INJECTION
`INTRAPERITONEAL; INJECTION
`INTRAPLEURAL; (cid:9) INJECTION
`INTRASYNOVIAL; INJECTION
`INTRATHECAL; (cid:9) INJECTION
`INTRATUMOR; (cid:9) INJECTION
`INTRAVENOUS; (cid:9) INJECTION
`INTRAVENOUS; POWDER, FOR INJECTION SOLUTION
`INTRAVENOUS; (cid:9) SOLUTION, (cid:9) INJECTION
`IV - SC; (cid:9) INJECTION
`IV(INFUSION); (cid:9) INJECTION
`IV(INcUSION); POWDER, FOR INJECTION SOLUTION
`IV(INFUSION); SOLUTION, (cid:9) INJECTION
`NERVE BLOCK; (cid:9) INJECTION
`ORAL; CAPSULE
`ORAL; CAPSULE, SOFT GELATIN
`ORAL; CAPSULE, SUSTAINED ACTION
`ORAL; CONCENTRATE
`ORAL; SOLUTION
`ORAL; (cid:9) SUSPENSION
`ORAL; TABLET
`ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
`ORAL; (cid:9) TABLET, (cid:9) SUSTAINED ACTION
`SOFT TISSUE; (cid:9) INJECTION
`SUBCONJUNCTIVAL; INJECTION
`SUBCUTANEOUS; (cid:9) INJECTION
`SUBCUTANEOUS; POWDER, FOR INJECTION SOLUTION
`TOPICAL; EMULSION, (cid:9) CREAM
`TOPICAL; LOTION
`TOPICAL; OINTMENT
`TOPICAL; SOLUTION
`TOPICAL; SUPPOSITORY
`URETERAL; SOLUTION
`VAGINAL; EMULSION, CREAM
`VAGINAL; SUPPOSITORY
`BENZYL BENZOATE
`INTRAMUSCULAR; (cid:9) INJECTION
`BENZYL CHLORIDE
`INTRAVENOUS; (cid:9) INJE