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BENZPHETAMINE HYDROCHLORIDE

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ACTIVE PHARMA INGREDIENTS

10 API Suppliers, 8 USDMF, 1 EU WC, 3 NDC API, 4 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

13 FDF Dossiers, 13 FDA Orange Book

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 6 SPI Pharma, 5 DKSH, 4 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 19 BASF, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 11 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 38 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 26 Roquette, 13 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

66 Fillers, Diluents & Binders, 52 Coating Systems & Additives, 30 Controlled & Modified Release, 23 Direct Compression, 22 Thickeners and Stabilizers, 21 Solubilizers, 19 Disintegrants & Superdisintegrants, 19 Granulation, 18 Lubricants & Glidants, 18 Film Formers & Plasticizers, 13 Co-Processed Excipients, 12 Topical, 12 Parenteral, 11 Taste Masking, 8 Chewable & Orodispersible Aids, 7 Emulsifying Agents, 6 API Stability Enhancers, 5 Rheology Modifiers, 5 Empty Capsules, 4 Coloring Agents, 4 Vegetarian Capsules, 2 Surfactant & Foaming Agents, 1 Soft Gelatin

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2 Regulatory FDF Prices

2 Regulatory FDF Prices

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1 USP, 5 Others

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/03/2025	Chattem Chemicals, Inc	U.S.A	CHATTEM CHEMICALS INC	18893	BENZPHETAMINE HYDROCHLORIDE	2005-10-21	Active	II	N/A
28/03/2025	CHEMICA INC	U.S.A	CHEMICA INC	16687	BENZPHETAMINE HYDROCHLORIDE	2003-07-09	Inactive	II	N/A

BENZPHETAMINE HYDROCHLORIDE

BENZPHETAMINE HYDROCHLORIDE

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

10 API Suppliers

8 USDMF

1 EU WC

3 NDC API

4 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

13 FDF Dossiers

13 FDA Orange Book

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

6 SPI Pharma

5 DKSH

4 Faran Shimi Pharmaceutical

1 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

1 ACG Worldwide

5 Actylis

1 Aeon Procare

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

19 BASF

10 Corel Pharma Chem

6 DFE Pharma

1 Finar

11 Gangwal Chemicals

7 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

38 Kerry

3 Kima Chemical

6 Lonza Capsugel

14 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

3 Novo Excipients

3 Pharmatrans-Sanaq

4 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

26 Roquette

13 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

2 The Dow Chemical Company

4 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

66 Fillers, Diluents & Binders

52 Coating Systems & Additives

30 Controlled & Modified Release

23 Direct Compression

22 Thickeners and Stabilizers

21 Solubilizers

19 Disintegrants & Superdisintegrants

19 Granulation

18 Lubricants & Glidants

18 Film Formers & Plasticizers

13 Co-Processed Excipients

12 Topical

12 Parenteral

11 Taste Masking

8 Chewable & Orodispersible Aids

7 Emulsifying Agents

6 API Stability Enhancers

5 Rheology Modifiers

5 Empty Capsules

4 Coloring Agents

4 Vegetarian Capsules

2 Surfactant & Foaming Agents

TABLET;ORAL - 25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons