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VALIUM

NDA

DIAZEPAM | N016087 | HOFFMANN LA ROCHE INC

1 strength0 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

3 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Roxane Laboratories, Inc. FDA-1985-P-0507 Roxane Laboratories, Inc. filed this petition on December 5, 1985, requesting that the FDA determine whether Diazepam Intensol (Concentrated Oral Solution) 5 mg per ml is suitable for an ANDA application, positioning it as similar to the listed drug Valium Tablets 5 mg and arguing that the concentra	505(q)	2026-02-09	Granted	Roxane Laboratories
Suitability Citizen Petition from Lachman Consultant Services, Inc FDA-2023-P-4300 Lachman Consultant Services, Inc. filed this suitability petition on behalf of a client requesting that the FDA declare Diazepam Injection USP, 20 mg/4 mL (5 mg/mL) single dose prefilled syringe suitable for submission as an ANDA under Section 505(j)(2)(C) of the FD&C Act, with the proposed product	Suitability	2023-10-04	Open	Lachman Consultant Services
Suitability Petition from Lachman Consulting Services Inc FDA-2022-P-0118 Lachman Consulting Services Inc. filed a petition under section 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Diazepam Injection USP, 20 mg/4 mL (5 mg/mL) single dose prefilled syringe suitable for submission as an abbreviated new drug application (ANDA), w	Suitability	2022-02-03	Open	Lachman Consulting Services Inc

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain5 active DMFs3 inactive

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

CAMBREX PROFARMACO MILANO SRLDIAZEPAM

DMF 14781970

FIS FABBRICA ITALIANA SINTETICI SPADIAZEPAM

DMF 31641978

CENTAUR PHARMACEUTICALS PRIVATE LTDDIAZEPAM USP

DMF 218602008

R L FINE CHEM PVT LTDDIAZEPAM

DMF 338582019

NAVINTA LLCDIAZEPAM USP

DMF 388442023

DELMAR CHEMICALS INCInactiveDIAZEPAM USP BULK

DMF 25821976

GEDEON RICHTER LTDInactiveDIAZEPAM USP

DMF 60711985

FDC PRIVATE LTDInactiveDIAZEPAM U.S.P. XXI

DMF 70251987

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 7, 2002	SUPPL -79	View Letter (PDF)
Feb 7, 2002	SUPPL -81	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.