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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Bayer Healthcare Llc

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17 ALPHA-ETHINYL-19-NOR-TESTOSTERONE

17A-ETHINYL-19-NOR-TESTOSTERONE ACETATE

5-AMINOSALICYLIC ACID

6-METHYLPREDNISOLNE

6-METHYLPREDNISOLONE-21-HEMISUCCINATE

6a-METHYLPREDNISOLONE-21-ACETATE

ACARBOSE

ACEMETACIN

ACETYLSALICYLIC ACID (ASPIRIN)

AMIDOTRIZOIC ACID (UROGRAFIN ACID)

AMPICILLIN

AMPICILLIN SODIUM STERILE

AMPICILLIN TRIHYDRATE

ASOPRISNIL

ASPIRIN USP

ATAMESTANE

AZELAIC ACID

AZELAIC ACID (A)

BAY 1903149 (THORIUM-227 CHLORIDE)

BAY Y 3118 DRUG SUBSTANCE

BAYPRESS R(NITRENDIPINE)TABLETS 5MG.,10MG.AND 20MG.

BETAMETHASONE

BETAMETHASONE VALERATE

BOLDENONE UNDECYLENATE

Blood Agar Base

CIPROFLOXACIN

CIPROFLOXACIN HYDRATED DRUG SUBSTANCE

CIPROFLOXACIN HYDROCHLORIDE

CIPROFLOXACIN OD

CLOCORTOLINE TRIMETHYL ACETATE

CLOTRIMAZOLE

CYPROTERONE ACETATE

CYPROTERONE ACETATE AS PRODUCED IN THE BERLIN-WEDDING PLANT

DANAZOL

DEFLAZACORT

DIENOGEST

DIFLUCORTOLONE-21-VALERATE

DROSPIRENONE

DROXONE

EDRUL TABS (20,30 & 240MG)

ELTANOLONE

EOB-DTPA

ESTRADIOL

ESTRADIOL ENANTHATE

ESTRADIOL VALERATE

ESTRADIOL-3-BENZOATE

ESTRIOL

ESTRONE

ETHINAMATE

ETHINYL ESTRADIOL

ETHINYLESTRADIOL-BETA-CYCLODEXTRIN-CLATHRATE

ETOFENAMATE

Estradiol hemihydrate

Estradiol valerate Micronised (micro 20)

Estriol Micro 20

FACILITIES AND PERSONNEL AT WUPPERTAL, WEST GERMANY

FACILITIES AND PERSONNEL IN LEVERKUSEN, GERMANY

FACILITIES FOR THE G OF LIQUID & SOFT GELATIN CAPSULE PRODUCTS

FACILITY AND OPERATING PROCEDURES IN DORMAGEN, WEST GERMANY

FLUDARA FILM-COATED TABLETS

FLUDARABINE PHOSPHATE

FLUOCORTIN BUTYLESTER (RECOMMENDED GENERIC NAME IS FLUOCORTIN BUTYL)

G. AND CONTROL OF CLINICAL SUPPLIES IN BERLIN, W. GERMANY

GADOBUTROL

GADOPENTETIC ACID,MEGLUMINE SALT

GEN. OPERATING PROCEDS FOR BULK PRODUCTS-SCHERING AG BERGKAMEN PLANT

GENERAL OPERATING PROCEDURE

GENERAL OPERATING PROCEDURES

GENERAL OPERATING PROCEDURES FOR BULK PRODUCTS

GESTODENE

Gadobutrol monohydrate

HYDROCORTISONE

HYDROCORTISONE ACETATE

HYDROCORTISONE HEMISUCCINATE

HYDROCORTISONE-17 VALERATE

HYDROXY ACID

HYDROXYPROGESTERONE CAPROATE

ILOPROST

ILOPROST B-CYCLODEXRIN CLATHRATE

IOPROMIDE

IOTROL USING 5-NITROISOPHTHALIC ACID AS STARTING MATERIAL

IPODATE SODIUM

ISONIAZID (NEOTEBEN)

L-5-HYDROXYTRYPTOPHAN

LEVONORGESTREL

LEVONORGESTREL (DCM)

LISURIDE HYDROGEN MALEATE

LISURIDE HYDROGEN MELEATE

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

MEDROXYPROGESTERONE ACETATE

MEGESTROL ACETATE

MEGLUMINE (D(-) N- METHYLGLUIAMINE)

MESTEROLONE (SH723)

MESTRANOL

METHYLTESTOSTERONE

METRIFONATE DRUG PRODUCT

METRIFONATE DRUG SUBSTANCE

MICRONIZED PREDNISONE

MICRONIZING LORMETAZEPAM

MS-275

MS-275 FILM-COATED TABLETS

MUZOLIMINE SEMIHYDRATE

MYCOSPOR (BIFONAZOLE) CREAM 1%

MYCOSPOR (BIFONAZOLE) SOLUTION 1%

Moxifloxacin hydrochloride

Moxifloxacin hydrochloride For use in the manufacture of parenteral preparations

NANDROLONE DECANOATE

NANDROLONE PHENPROPIONATE

NANDROLONE PHENPROPIONATE,17 B-(3-PHENYLPROPIONYLOXY-)4-ESTREN-3-ONE

NICLOSAMIDE 500MG TABLET

NICLOSAMIDE ANHYDROUS DRUG SUBSTANCE

NIFEDIPINE DRUG SUBSTANCE

NIMODIPINE CAPS 10MG (bay e 9736)

NISOLDIPINE

NITRENDIPINE, RAW MATERIAL SUB.(TM:BAYPRESS)

NOCLOPROST BETA-CYCLODEXTRIN CLATHRATE

NORETHINDRONE

NORETHINDRONE ACETATE

NORETHISTERONE

NORETHISTERONE ENANTHATE

NORGESTREL

NORPLANT (LEVONORGESTREL IMPLANTS)

ONAPRISTONE

PANCURONIUM BROMIDE

PARACETAMOL

PIRAZOLAC

PREDNISOLONE

PREDNISOLONE 21-DISODIUM PHOSPHATE

PREDNISOLONE 21-HEMISUCCINATE

PREDNISOLONE-21-ACETATE

PYNASUNATE

QUINESTROL

QUINIDINE GLUCONATE

RIVAROXABAN (MICRONIZED) DRUG SUBSTANCE

RIVAROXABAN COATED TABLETS, 10 MG

ROLIPRAM AS PRODUCED IN THE BERLIN PLANT

SALAZOSULFAPYRIDINE

SALAZOSULFAPYRIDINE AS PRODUCED IN THE BERGKAMEN PLANT

SH-714

SPIRONOLACTONE

TESTOSTERONE

TESTOSTERONE ENANTHATE

TESTOSTERONE PROPIONATE

TESTOSTERONE UNDECANOATE

TESTOSTERONE UNDECANOATE 750 MG I.M.

TRASYLOL (APROTININ) DRUG PRODUCT

TRASYLOL (APROTININ)-DRUG SUBSTANCE

ZK 112 119(6-BOCIP)

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Status - Active

Status - Inactive

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EXPIRED

VALID

WITHDRAWN BY HOLDER

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218MF10828

218MF10829

218MF10941

219MF10281

221MF10003

222MF10134

224MF10001

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
5-AMINOSALICYLIC ACID
Issue/Submission Date
1984-11-09
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Mesalazine
Issue/Submission Date
2017-03-01
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Mesalazine at 13353 Berlin, Mueller...
Issue/Submission Date
2012-01-16
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
5-AMINOSALICYLIC ACID
Mesalazine
Mesalazine at 13353 Berlin, Mueller...
Issue/Submission Date
1984-11-09
2017-03-01
2012-01-16
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
6-METHYLPREDNISOLNE
Issue/Submission Date
1982-06-14
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
6-METHYLPREDNISOLNE
Issue/Submission Date
1982-06-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ACARBOSE
Issue/Submission Date
1990-04-23
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Acarbose
Issue/Submission Date
2018-03-06
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
ACARBOSE
Acarbose
Issue/Submission Date
1990-04-23
2018-03-06
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ACEMETACIN
Issue/Submission Date
1989-01-09
Supporting Info
CEP/COS

Application Number
Status
EXPIRED
Filing Details
Acemetacin Unmilled, milled
Issue/Submission Date
2017-03-06
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
EXPIRED
 
Filing Details
ACEMETACIN
Acemetacin Unmilled, milled
Issue/Submission Date
1989-01-09
2017-03-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ETHINYLESTRADIOL-BETA-CYCLODEXTRIN-...
Issue/Submission Date
2000-07-25
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ETHINYLESTRADIOL-BETA-CYCLODEXTRIN-...
Issue/Submission Date
2000-07-25
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
AMIDOTRIZOIC ACID (UROGRAFIN ACID)
Issue/Submission Date
1966-12-02
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
AMIDOTRIZOIC ACID (UROGRAFIN ACID)
Issue/Submission Date
1966-12-02
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
AMPICILLIN
Issue/Submission Date
1998-09-01
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
AMPICILLIN
Issue/Submission Date
1998-09-01
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
AMPICILLIN SODIUM STERILE
Issue/Submission Date
1989-06-15
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
AMPICILLIN SODIUM STERILE
Issue/Submission Date
1989-06-15
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
AMPICILLIN TRIHYDRATE
Issue/Submission Date
1998-09-01
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
AMPICILLIN TRIHYDRATE
Issue/Submission Date
1998-09-01
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
TRASYLOL (APROTININ)-DRUG SUBSTANCE
Issue/Submission Date
1981-07-15
Supporting Info
CEP/COS

Application Number
Status
WITHDRAWN BY HOLDER
Filing Details
Aprotinin concentrated solution
Issue/Submission Date
2011-09-15
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
WITHDRAWN BY HOLDER
 
Filing Details
TRASYLOL (APROTININ)-DRUG SUBSTANCE
Aprotinin concentrated solution
Issue/Submission Date
1981-07-15
2011-09-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
TRASYLOL (APROTININ) DRUG PRODUCT
Issue/Submission Date
1992-08-14
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
TRASYLOL (APROTININ) DRUG PRODUCT
Issue/Submission Date
1992-08-14
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ASOPRISNIL
Issue/Submission Date
2004-07-15
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ASOPRISNIL
Issue/Submission Date
2004-07-15
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ACETYLSALICYLIC ACID (ASPIRIN)
Issue/Submission Date
1983-01-14
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Acetylsalicylic acid
Issue/Submission Date
2011-04-15
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
ACETYLSALICYLIC ACID (ASPIRIN)
Acetylsalicylic acid
Issue/Submission Date
1983-01-14
2011-04-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ASPIRIN USP
Issue/Submission Date
2000-11-20
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ASPIRIN USP
Issue/Submission Date
2000-11-20
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ATAMESTANE
Issue/Submission Date
1990-08-02
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ATAMESTANE
Issue/Submission Date
1990-08-02
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
AZELAIC ACID
Issue/Submission Date
1991-08-07
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
AZELAIC ACID
Issue/Submission Date
1991-08-07
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
AZELAIC ACID (A)
Issue/Submission Date
2014-06-26
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
AZELAIC ACID (A)
Issue/Submission Date
2014-06-26
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
BAY Y 3118 DRUG SUBSTANCE
Issue/Submission Date
1992-09-08
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
BAY Y 3118 DRUG SUBSTANCE
Issue/Submission Date
1992-09-08
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
NOCLOPROST BETA-CYCLODEXTRIN CLATHR...
Issue/Submission Date
1990-02-02
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
NOCLOPROST BETA-CYCLODEXTRIN CLATHR...
Issue/Submission Date
1990-02-02
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Estradiol hemihydrate
Issue/Submission Date
2017-03-01
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Estradiol hemihydrate
Issue/Submission Date
2017-03-01
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
BETAMETHASONE
Issue/Submission Date
1985-05-07
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
BETAMETHASONE
Issue/Submission Date
1985-05-07
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
BETAMETHASONE VALERATE
Issue/Submission Date
1985-05-22
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
BETAMETHASONE VALERATE
Issue/Submission Date
1985-05-22
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
MYCOSPOR (BIFONAZOLE) CREAM 1%
Issue/Submission Date
1984-05-31
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
MYCOSPOR (BIFONAZOLE) CREAM 1%
Issue/Submission Date
1984-05-31
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
MYCOSPOR (BIFONAZOLE) SOLUTION 1%
Issue/Submission Date
1985-04-09
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
MYCOSPOR (BIFONAZOLE) SOLUTION 1%
Issue/Submission Date
1985-04-09
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
BOLDENONE UNDECYLENATE
Issue/Submission Date
1984-03-28
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
BOLDENONE UNDECYLENATE
Issue/Submission Date
1984-03-28
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CIPROFLOXACIN
Issue/Submission Date
1991-02-28
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Ciprofloxacin
Issue/Submission Date
2017-03-06
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
CIPROFLOXACIN
Ciprofloxacin
Issue/Submission Date
1991-02-28
2017-03-06
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CIPROFLOXACIN HYDRATED DRUG SUBSTAN...
Issue/Submission Date
1993-07-13
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CIPROFLOXACIN HYDRATED DRUG SUBSTAN...
Issue/Submission Date
1993-07-13
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CIPROFLOXACIN OD
Issue/Submission Date
1999-07-28
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CIPROFLOXACIN OD
Issue/Submission Date
1999-07-28
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CIPROFLOXACIN HYDROCHLORIDE
Issue/Submission Date
1989-07-14
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Ciprofloxacin Hydrochloride
Issue/Submission Date
2017-03-06
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride
Issue/Submission Date
1989-07-14
2017-03-06
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CLOCORTOLINE TRIMETHYL ACETATE
Issue/Submission Date
1973-02-13
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CLOCORTOLINE TRIMETHYL ACETATE
Issue/Submission Date
1973-02-13
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CLOTRIMAZOLE
Issue/Submission Date
1987-01-15
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Clotrimazole
Issue/Submission Date
2011-07-28
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
CLOTRIMAZOLE
Clotrimazole
Issue/Submission Date
1987-01-15
2011-07-28
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CYPROTERONE ACETATE
Issue/Submission Date
1973-02-01
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Cyproterone acetate Variant 1
Issue/Submission Date
2017-03-03
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
CYPROTERONE ACETATE
Cyproterone acetate Variant 1
Issue/Submission Date
1973-02-01
2017-03-03
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CYPROTERONE ACETATE AS PRODUCED IN ...
Issue/Submission Date
1983-12-20
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CYPROTERONE ACETATE AS PRODUCED IN ...
Issue/Submission Date
1983-12-20
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
DANAZOL
Issue/Submission Date
1988-06-30
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
DANAZOL
Issue/Submission Date
1988-06-30
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DANAZOL
Issue/Submission Date
1988-06-29
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
DANAZOL
Issue/Submission Date
1988-06-29
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DEFLAZACORT
Issue/Submission Date
1983-03-17
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
DEFLAZACORT
Issue/Submission Date
1983-03-17
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DIENOGEST
Issue/Submission Date
1999-02-26
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
DIENOGEST
Issue/Submission Date
1999-02-26
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DIFLUCORTOLONE-21-VALERATE
Issue/Submission Date
1984-07-18
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Valerate diflucortolone at Kaiser-W...
Issue/Submission Date
2006-11-24
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
DIFLUCORTOLONE-21-VALERATE
Valerate diflucortolone at Kaiser-W...
Issue/Submission Date
1984-07-18
2006-11-24
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DROSPIRENONE
Issue/Submission Date
1996-09-09
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Drospirenone Micronised (micro 15)
Issue/Submission Date
2017-03-01
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
DROSPIRENONE
Drospirenone Micronised (micro 15)
Issue/Submission Date
1996-09-09
2017-03-01
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
EDRUL TABS (20,30 & 240MG)
Issue/Submission Date
1986-01-10
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
EDRUL TABS (20,30 & 240MG)
Issue/Submission Date
1986-01-10
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ELTANOLONE
Issue/Submission Date
1994-01-31
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ELTANOLONE
Issue/Submission Date
1994-01-31
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
MS-275 FILM-COATED TABLETS
Issue/Submission Date
2007-05-02
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
MS-275 FILM-COATED TABLETS
Issue/Submission Date
2007-05-02
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
MS-275
Issue/Submission Date
2007-05-02
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
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MS-275
Issue/Submission Date
2007-05-02
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ESTRADIOL VALERATE
Issue/Submission Date
1978-11-02
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Estradiol hemihydrate at Kaiser-Wil...
Issue/Submission Date
2010-04-13
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ESTRADIOL VALERATE
Estradiol hemihydrate at Kaiser-Wil...
Issue/Submission Date
1978-11-02
2010-04-13
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ESTRADIOL
Issue/Submission Date
1982-10-13
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ESTRADIOL
Issue/Submission Date
1982-10-13
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ESTRADIOL-3-BENZOATE
Issue/Submission Date
1982-10-13
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ESTRADIOL-3-BENZOATE
Issue/Submission Date
1982-10-13
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ESTRADIOL ENANTHATE
Issue/Submission Date
1967-10-25
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ESTRADIOL ENANTHATE
Issue/Submission Date
1967-10-25
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Estradiol valerate Micronised (micr...
Issue/Submission Date
2017-03-01
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Estradiol valerate Micronised (micr...
Issue/Submission Date
2017-03-01
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
ESTRIOL
Issue/Submission Date
1997-04-18
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
ESTRIOL
Issue/Submission Date
1997-04-18
Supporting Info
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USDMF

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Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Estriol Micro 20
Issue/Submission Date
2018-08-01
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Estriol Micro 20
Issue/Submission Date
2018-08-01
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ESTRONE
Issue/Submission Date
1994-08-01
Supporting Info
CEP/COS

Application Number
Status
Filing Details