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BENZPHETAMINE HYDROCHLORIDE

ANDA

BENZPHETAMINE HYDROCHLORIDE | A040578 | SCINOPHARM TAIWAN LTD

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Lachman Consultant Services, Inc. - Citizen Petition FDA-2008-P-0215 · 6 docket documents Lachman Consultant Services, Inc. filed this petition on January 2, 2008, requesting that the FDA determine whether Didrex 25 mg tablets (benzphetamine hydrochloride, NDA 12-427) manufactured by Pharmacia and Upjohn Company was voluntarily withdrawn from sale for safety or effectiveness reasons unde	505(q)	2008-07-03	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain3 active DMFs6 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

CHATTEM CHEMICALS INCBENZPHETAMINE HYDROCHLORIDE

DMF 188932005

OLON SPABENZPHETAMINE HYDROCHLORIDE

DMF 213192008

EMCURE PHARMACEUTICALS LTDBENZPHETAMINE HYDROCHLORIDE USP

DMF 239442010

SIEGFRIED AGInactiveBENZPHETAMINE HYDROCHLORIDE

DMF 57031985

HEXAGON LABORATORIES INCInactiveBENZPHETAMINE HYDROCHLORIDE

DMF 69621987

CHEMICA INCInactiveBENZPHETAMINE HYDROCHLORIDE

DMF 166872003

SIEGFRIED LTDInactiveBENZPHETAMINE HYDROCHLORIDE

DMF 205632007

CORDEN PHARMACHEMInactiveBenzphetamine Hydrochloride

DMF 210902007

MALLINCKRODT INCInactiveBENZPHETAMINE HYDROCHLORIDE, CODE 9223

DMF 220402008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 20, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 17, 2006

No patent or exclusivity listings for this strength.