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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Daiichi Sankyo Co Ltd

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BENICAR HCTR (OLMESARTAN MEDOXOMIL HYDROCHLOROTHIAZIDE) TABLETS

BENICAR(TM) TABLETS 5 MG, 20 MG AND 40 MG

BULK CS-045 ORAL HYPOGLYCEMIC

BULK FORM OF NIMUSTINE HCL (NIDRAN)

Bimatoprost (production only)

Breakfast class crepe de Chine sodium (production only)

CEFMETAZOLE (FREE ACID)

CEFMETAZOLE SODIUM INJECTION(VIALS)

CETRAXATE HCl CAPSULES

CETRAXATE HYDROCHLORIDE

CS-003 DRUG PRODUCT

CS-003 DRUG SUBSTANCE

CS-011 DRUG PRODUCT

CS-023 DRUG SUBSTANCE

CS-088 DRUG SUBSTANCE

CS-505 DRUG PRODUCT

CS-505 DRUG SUBSTANCE

CS-514BULK SUBSTANCE PROCESSED TANASHI(TOKYO)& SHINAGAWA(TOKYO)PLANTS

CS-615 DRUG PRODUCT

CS-622 DRUG SUBSTANCE

CS-622 FINISHED DOSAGE FORM

CS-758 DRUG PRODUCT

CS-758 DRUG SUBSTANCE

CS-780 DRUG PRODUCT

CS-780 DRUG SUBSTANCE

CS-807 CEFPODOXIME PROXETIL DRUG SUBSTANCE

CS-807 TABLETS

CS-834 DRUG PRODUCT

CS-834 DRUG SUBSTANCE

CS-866 DRUG PRODUCT

CS-866 DRUG SUBSTANCE

CS-866(5 10 20 & 40MG) TABLETS

CS-866-HYDROCHLOROTHIAZIDE TABLETS (CS-866HCTZ)

CS-917 DRUG PRODUCT

CS-917 DRUG SUBSTANCE

DATICHI PHARMACEUTICAL CO LTD DU-6859A

DE-310 DRUG SUBSTANCE

DF-4639 INTERMEDIATE

DK-507K DRUG SUBSTANCE

DL 8280 MEFOXACIN A & PLACEBO TABS

DL-8280 CAPSULES

DL-8280, BULK FORM

DR-3355 BULK SUBSTANCE

DS-4152 DRUG SUBSTANCE

DT-5621 DRUG SUBSTANCE

DU-176B DRUG SUBSTANCE

DW-908E DRUG SUBSTANCE

DX-619 DRUG SUBSTANCE

DX-8951F DRUG SUBSTANCE

DX-9065A

DZ-697B DRUG SUBSTANCE

EPIRIZOLE (MEBRON)

FACILITIES AND OPERATING PROCEDURES IN HIRATSUKA-SHI, JAPAN

Influenza HA vaccine stock solution for intradermal

Japan Pharmaceutical Codex panthenol (production only)

Japan Pharmaceutical Codex sugar-containing iron oxide (production only)

Japanese Pharmacopoeia Loxoprofensodium hydrate \"production-only\"

Japanese Pharmacopoeia Pirushikainido hydrochloride hydrate (production only)

Japanese Pharmacopoeia alprostadil alpha dexfenfluramine (production only)

Japanese Pharmacopoeia benidipine hydrochloride (production only)

Japanese Pharmacopoeia calcium pantothenate (production only)

Japanese Pharmacopoeia dl- methyl ephedrine hydrochloride (production only)

Japanese Pharmacopoeia dopamine hydrochloride (production only)

Japanese Pharmacopoeia olopatadine hydrochloride (production only)

Japanese Pharmacopoeia procaine hydrochloride (production only)

Japanese Pharmacopoeia pyridoxine hydrochloride (production only)

Japanese Pharmacopoeia riboflavin butyric acid ester (production only)

Japanese Pharmacopoeia sodium valproate (production only)

Japanese Pharmacopoeia valsartan (production only)

L-PHENYLALANINE

L-TRYPTOPHAN

L-VALINE

LEVOFLOXACIN DRUG SUBSTANCE

Latanoprost

Levodopa

MAAA-1162A

MALOTILATE 200 MG TABLETS

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN EDOGAWA-KU, TOKYO, JAPAN.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SHIZUOKA JAPAN.

METHIONINE-ENKEPHALIN

MIX-RR

MUCOPOLYSACCHARIDE POLYSULFATE DRUG SUBSTANCE

NIMUSTINE HCL (NIDRAN) IN VIALS

OFLOXACIN BULK PRODUCT

OLMESARTAN MEDOXOMIL DRUG SUBSTANCE

Oxycodone hydrochloride hydrate

PANTETHINE BULK SUBSTANCE

PANTOSIN 200 MG TABLETS

PARENTERAL FORMULATION FACILITY IN OSAKA, JAPAN.

PRAVASTATIN SODIUM DRUG SUBSTANCE

PRODUCTION TECHNOLOGY RESEARCH LABS., EDOGAWA-KU, TOKYO, JAPAN

SUN11031 (HUMAN GHRELIN) DRUG SUBSTANCE

SUN13834 DRUG SUBSTANCE

SUN13837 DRUG SUBSTANCE

TRANEXAMIC ACID

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Status - Active

Status - Inactive

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VALID

WITHDRAWN BY HOLDER

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217MF10114

217MF10115

217MF10117

217MF10383

218MF10946

219MF10170

220MF10069

221MF10083

221MF10100

221MF10143

222MF10065

222MF10113

222MF10235

224MF10081

224MF10082

225MF10008

225MF10209

225MF10222

226MF10140

226MF10163

227MF10058

227MF10113

227MF10164

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
DU-176B DRUG SUBSTANCE
Issue/Submission Date
2004-02-13
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 - Unpaid
DMF Review - N/A
 
Filing Details
DU-176B DRUG SUBSTANCE
Issue/Submission Date
2004-02-13
Supporting Info
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USDMF

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

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

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia alprostadil ...
Issue/Submission Date
2006-11-24
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Japanese Pharmacopoeia alprostadil ...
Issue/Submission Date
2006-11-24
Supporting Info
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USDMF

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

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

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia benidipine h...
Issue/Submission Date
2013-11-14
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Japanese Pharmacopoeia benidipine h...
Issue/Submission Date
2013-11-14
Supporting Info
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USDMF

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

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

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia Pirushikaini...
Issue/Submission Date
2015-03-06
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Japanese Pharmacopoeia Pirushikaini...
Issue/Submission Date
2015-03-06
Supporting Info
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USDMF

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

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

Application Number
Status
 
Filing Details
Bimatoprost (production only) at Ta...
Issue/Submission Date
2012-04-13
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Bimatoprost (production only) at Ta...
Issue/Submission Date
2012-04-13
Supporting Info
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USDMF

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

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

Application Number
Status
 
Filing Details
Breakfast class crepe de Chine sodi...
Issue/Submission Date
2013-12-03
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Breakfast class crepe de Chine sodi...
Issue/Submission Date
2013-12-03
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CS-088 DRUG SUBSTANCE
Issue/Submission Date
2004-06-14
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 - Unpaid
DMF Review - N/A
 
Filing Details
CS-088 DRUG SUBSTANCE
Issue/Submission Date
2004-06-14
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CEFMETAZOLE (FREE ACID)
Issue/Submission Date
1982-09-03
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
CEFMETAZOLE (FREE ACID)
Issue/Submission Date
1982-09-03
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CEFMETAZOLE SODIUM INJECTION(VIALS)
Issue/Submission Date
1985-08-14
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 - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
CEFMETAZOLE SODIUM INJECTION(VIALS)
Issue/Submission Date
1985-08-14
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CS-807 CEFPODOXIME PROXETIL DRUG SU...
Issue/Submission Date
1987-04-15
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 - Unpaid
DMF Review - N/A
 
Filing Details
CS-807 CEFPODOXIME PROXETIL DRUG SU...
Issue/Submission Date
1987-04-15
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CETRAXATE HYDROCHLORIDE
Issue/Submission Date
1982-02-05
Supporting Info
CEP/COS

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

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia cetraxate hy...
Issue/Submission Date
2010-02-22
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
CETRAXATE HYDROCHLORIDE
Japanese Pharmacopoeia cetraxate hy...
Issue/Submission Date
1982-02-05
2010-02-22
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CETRAXATE HCl CAPSULES
Issue/Submission Date
1982-02-05
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
CETRAXATE HCl CAPSULES
Issue/Submission Date
1982-02-05
Supporting Info
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USDMF

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

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

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia procaine hyd...
Issue/Submission Date
2010-03-23
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Japanese Pharmacopoeia procaine hyd...
Issue/Submission Date
2010-03-23
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CS-023 DRUG SUBSTANCE
Issue/Submission Date
2004-03-12
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
CS-023 DRUG SUBSTANCE
Issue/Submission Date
2004-03-12
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CS-807 TABLETS
Issue/Submission Date
1987-04-15
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 - Unpaid
DMF Review - N/A
 
Filing Details
CS-807 TABLETS
Issue/Submission Date
1987-04-15
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CS-514BULK SUBSTANCE PROCESSED TANA...
Issue/Submission Date
1985-08-29
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Pravastatin sodium
Issue/Submission Date
2016-06-14
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
VALID
 
Filing Details
CS-514BULK SUBSTANCE PROCESSED TANA...
Pravastatin sodium
Issue/Submission Date
1985-08-29
2016-06-14
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CS-615 DRUG PRODUCT
Issue/Submission Date
1998-10-19
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
CS-615 DRUG PRODUCT
Issue/Submission Date
1998-10-19
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CS-866 DRUG SUBSTANCE
Issue/Submission Date
1995-04-07
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 - Unpaid
DMF Review - N/A
 
Filing Details
CS-866 DRUG SUBSTANCE
Issue/Submission Date
1995-04-07
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
OLMESARTAN MEDOXOMIL DRUG SUBSTANCE
Issue/Submission Date
2000-07-14
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 - Unpaid
DMF Review - N/A
 
Filing Details
OLMESARTAN MEDOXOMIL DRUG SUBSTANCE
Issue/Submission Date
2000-07-14
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CS-866 DRUG PRODUCT
Issue/Submission Date
1995-04-07
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Olmesartan medoxomil
Issue/Submission Date
2018-10-10
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
VALID
 
Filing Details
CS-866 DRUG PRODUCT
Olmesartan medoxomil
Issue/Submission Date
1995-04-07
2018-10-10
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CS-866(5 10 20 & 40MG) TABLETS
Issue/Submission Date
2000-05-15
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 - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
CS-866(5 10 20 & 40MG) TABLETS
Issue/Submission Date
2000-05-15
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CS-917 DRUG PRODUCT
Issue/Submission Date
2003-04-22
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 - Unpaid
DMF Review - N/A
 
Filing Details
CS-917 DRUG PRODUCT
Issue/Submission Date
2003-04-22
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CS-917 DRUG SUBSTANCE
Issue/Submission Date
2003-04-28
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 - Unpaid
DMF Review - N/A
 
Filing Details
CS-917 DRUG SUBSTANCE
Issue/Submission Date
2003-04-28
Supporting Info
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USDMF

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

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

Application Number
Status
 
Filing Details
Japan Pharmaceutical Codex pantheno...
Issue/Submission Date
2005-05-24
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Japan Pharmaceutical Codex pantheno...
Issue/Submission Date
2005-05-24
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
DL-8280, BULK FORM
Issue/Submission Date
1982-09-28
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Ofloxacin
Issue/Submission Date
2015-08-04
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
VALID
 
Filing Details
DL-8280, BULK FORM
Ofloxacin
Issue/Submission Date
1982-09-28
2015-08-04
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
DL-8280 CAPSULES
Issue/Submission Date
1982-09-28
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 - Unpaid
DMF Review - N/A
 
Filing Details
DL-8280 CAPSULES
Issue/Submission Date
1982-09-28
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
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia dopamine hyd...
Issue/Submission Date
2010-09-30
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Japanese Pharmacopoeia dopamine hyd...
Issue/Submission Date
2010-09-30
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
DR-3355 BULK SUBSTANCE
Issue/Submission Date
1990-05-14
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 - Unpaid
DMF Review - N/A
 
Filing Details
DR-3355 BULK SUBSTANCE
Issue/Submission Date
1990-05-14
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
DX-9065A
Issue/Submission Date
1998-09-17
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
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Status
Status - Inactive
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DMF Review - N/A
 
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DX-9065A
Issue/Submission Date
1998-09-17
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CEP/COS

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Japanese DMF

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Japanese Pharmacopoeia dl- methyl e...
Issue/Submission Date
2009-07-09
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Japanese Pharmacopoeia dl- methyl e...
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2009-07-09
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USDMF

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Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
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EPIRIZOLE (MEBRON)
Issue/Submission Date
1976-06-15
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CEP/COS

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Status
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Issue/Submission Date
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Japanese DMF

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Status
 
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Issue/Submission Date
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Written Confirmation

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Status
Filing Details
Issue/Submission Date
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Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
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EPIRIZOLE (MEBRON)
Issue/Submission Date
1976-06-15
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USDMF

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Status
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CS-866-HYDROCHLOROTHIAZIDE TABLETS ...
Issue/Submission Date
2002-05-31
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CEP/COS

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Status
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Japanese DMF

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Status
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Status
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CS-866-HYDROCHLOROTHIAZIDE TABLETS ...
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2002-05-31
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USDMF

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Status
Status - Inactive
Facility Fees - Unpaid
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L-PHENYLALANINE
Issue/Submission Date
1987-04-02
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CEP/COS

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Status
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Issue/Submission Date
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Japanese DMF

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Status
 
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Written Confirmation

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Status
Filing Details
Issue/Submission Date
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Application Number
Status
Status - Inactive
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DMF Review - N/A
 
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L-PHENYLALANINE
Issue/Submission Date
1987-04-02
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USDMF

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Status
Status - Inactive
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L-TRYPTOPHAN
Issue/Submission Date
1983-05-31
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Status
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Issue/Submission Date
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Japanese DMF

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Status
 
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Written Confirmation

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Status
Filing Details
Issue/Submission Date
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Application Number
Status
Status - Inactive
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DMF Review - N/A
 
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L-TRYPTOPHAN
Issue/Submission Date
1983-05-31
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L-VALINE
Issue/Submission Date
1987-04-02
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Japanese DMF

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Status
 
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Status
Filing Details
Issue/Submission Date
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Status
Status - Inactive
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L-VALINE
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1987-04-02
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CEP/COS

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Latanoprost at Takaoka, Toyama Pref...
Issue/Submission Date
2008-02-25
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Latanoprost at Takaoka, Toyama Pref...
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2008-02-25
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USDMF

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CEP/COS

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WITHDRAWN BY HOLDER
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Levodopa
Issue/Submission Date
2008-05-14
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Japanese Pharmacopoeia levodopa at ...
Issue/Submission Date
2005-07-27
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WITHDRAWN BY HOLDER
 
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Levodopa
Japanese Pharmacopoeia levodopa at ...
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2008-05-14
2005-07-27
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USDMF

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Status
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LEVOFLOXACIN DRUG SUBSTANCE
Issue/Submission Date
1993-02-26
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Issue/Submission Date
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Japanese DMF

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Status
Status - Active
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LEVOFLOXACIN DRUG SUBSTANCE
Issue/Submission Date
1993-02-26
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USDMF

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Japanese Pharmacopoeia Loxoprofenso...
Issue/Submission Date
2009-04-22
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Japanese Pharmacopoeia Loxoprofenso...
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2009-04-22
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Status
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MALOTILATE 200 MG TABLETS
Issue/Submission Date
1984-05-03
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CEP/COS

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Status
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Issue/Submission Date
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Status
 
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Status
Filing Details
Issue/Submission Date
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Status
Status - Inactive
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MALOTILATE 200 MG TABLETS
Issue/Submission Date
1984-05-03
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USDMF

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Status
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METHIONINE-ENKEPHALIN
Issue/Submission Date
1986-12-08
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Status
 
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Status
Status - Inactive
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METHIONINE-ENKEPHALIN
Issue/Submission Date
1986-12-08
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USDMF

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Status
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BULK FORM OF NIMUSTINE HCL (NIDRAN)
Issue/Submission Date
1984-07-20
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CEP/COS

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Status
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Issue/Submission Date
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Japanese DMF

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Status
 
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Status
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Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
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BULK FORM OF NIMUSTINE HCL (NIDRAN)
Issue/Submission Date
1984-07-20
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USDMF

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Status
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NIMUSTINE HCL (NIDRAN) IN VIALS
Issue/Submission Date
1984-07-20
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CEP/COS

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Status
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Issue/Submission Date
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Japanese DMF

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Status
 
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Status
Filing Details
Issue/Submission Date
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Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
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NIMUSTINE HCL (NIDRAN) IN VIALS
Issue/Submission Date
1984-07-20
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USDMF

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Status
Status - Inactive
Facility Fees - Unpaid
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OFLOXACIN BULK PRODUCT
Issue/Submission Date
1986-05-29
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CEP/COS

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Status
Filing Details
Issue/Submission Date
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Japanese DMF

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Status
 
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Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
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OFLOXACIN BULK PRODUCT
Issue/Submission Date
1986-05-29
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USDMF

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BENICAR(TM) TABLETS 5 MG, 20 MG AND...
Issue/Submission Date
2004-09-14
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CEP/COS

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Status
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Issue/Submission Date
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Japanese DMF

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Status
Filing Details
Issue/Submission Date
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Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
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BENICAR(TM) TABLETS 5 MG, 20 MG AND...
Issue/Submission Date
2004-09-14
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BENICAR HCTR (OLMESARTAN MEDOXOMIL ...
Issue/Submission Date
2006-07-25
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CEP/COS

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Status
Status - Inactive
Facility Fees - Unpaid
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BENICAR HCTR (OLMESARTAN MEDOXOMIL ...
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2006-07-25
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Japanese Pharmacopoeia olopatadine ...
Issue/Submission Date
2014-07-31
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Japanese Pharmacopoeia olopatadine ...
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2014-07-31
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Japan Pharmaceutical Codex sugar-co...
Issue/Submission Date
2005-05-24
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Japan Pharmaceutical Codex sugar-co...
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2005-05-24
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Oxycodone hydrochloride hydrate at ...
Issue/Submission Date
2015-06-18
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2015-06-18
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PANTETHINE BULK SUBSTANCE
Issue/Submission Date
1990-12-11
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