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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

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 · 4 docket documents 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that FDA designate an alternative reference standard for ANDA applications for Chlordiazepoxide HC	Other	2018-09-11	Withdrawn	Centaur Pharmaceuticals Private Limited

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

Clinical Trials

5 trials from ClinicalTrials.gov, 4 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Gabapentin for Alcohol Withdrawal Syndrome NCT03012815	Phase 4	Completed	Mayo Clinic	88	2017-02-01 → 2021-03-01
Outpatient Treatment of Alcohol Withdrawal Syndrome NCT00136617	Phase 3	Completed	Hvidovre University Hospital	165	2003-08 → 2008-09
Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal NCT01573052	Phase 4	Completed	VA Salt Lake City Health Care System	26	2004-03 → 2010-09
Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder NCT01109030	Phase 2/3	Completed	Tehran University of Medical Sciences	50	2010-04 → 2011-10
A Study of the Use of Combination of Anti-cholinergic and Minor Tranquilliser in the Treatment of Non-cardiac Chest Pain - a Double Blind Placebo Controlled Study NCT00516854	N/A	UNKNOWN	Hospital Authority, Hong Kong	100	2002-06 → 2008-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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