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LIBRIUM

NDA

CHLORDIAZEPOXIDE HYDROCHLORIDE | N012249 | VALEANT PHARMACEUTICALS INTERNATIONAL

3 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 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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 21, 2016	SUPPL -49	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

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

#003 — 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

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