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CHLORDIAZEPOXIDE HYDROCHLORIDE

ANDA

CHLORDIAZEPOXIDE HYDROCHLORIDE | A084768 | BARR LABORATORIES INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Pharmaceutical R&D and QA Consulting Services on behalf... FDA-2018-P-3413 Dilip R. Sanvordeker, representing Centaur Pharmaceuticals Private Limited, filed this citizen petition under Section 505(i) of the Federal Food, Drug, and Cosmetic Act on September 7, 2018, requesting that FDA designate an alternative reference standard for ANDA applications for Chlordiazepoxide HC	Other	2018-09-11	Withdrawn	Pharmaceutical R&D and QA Consulting Services on behalf of Centaur Pharmaceuticals Private Limited

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

API Supply Chain3 active DMFs1 inactive

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

CAMBREX PROFARMACO MILANO SRLCHLORDIAZEPOXIDE HYDROCHLORIDE

DMF 7451963

RAKS PHARMA PVT LTDCHLORDIAZEPOXIDE HYDROCHLORIDE USP

DMF 351852020

ALEMBIC PHARMACEUTICALS LTDCHLORDIAZEPOXIDE HYDROCHLORIDE USP

DMF 356062021

DELMAR CHEMICALS LTDInactiveCHLORDIAZEPOXIDE HYDROCHLORIDE

DMF 23951975

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

Products (1)

#001 — 5MG

RLDAB

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.