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DIDREX

NDA

BENZPHETAMINE HYDROCHLORIDE | N012427 | PFIZER INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs5 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

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 9, 2020	SUPPL -31	View Letter (PDF)
Feb 17, 2010	SUPPL -26	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#002 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982