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DIAZEPAM

NDA

DIAZEPAM | N020124 | US ARMY MEDICAL RESEARCH MATERIEL COMMAND

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition Amendment from Newcastle Bioscience, LLC FDA-2023-P-4293 · 12 docket documents Newcastle Bioscience, LLC filed this amended suitability petition pursuant to Section 505(q) of the Federal Food, Drug, and Cosmetic Act on behalf of a client requesting that the FDA Commissioner declare that Glyburide-Glipizide Disintegrating Tablets in 6 milligram and 1 milligram strengths are sui	Suitability	2024-02-29	Granted	—

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

Clinical Trials

56 trials from ClinicalTrials.gov — 1 recruiting, 38 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Nonopioid Analgesia After Labral Surgery NCT03825809	Phase 2/3	Recruiting	Henry Ford Health System	100	2019-01-22 → 2020-05-20
Impact of a One-month Long Detoxification Diazepam Treatment on Early Alcohol Relapse NCT02242955	N/A	Completed	University Hospital, Lille	26	2014-07 → 2016-07
Repeat Dose Safety Study of NRL-1 in Epilepsy Subjects NCT02721069	Phase 3	Completed	Neurelis, Inc.	175	2016-04-11 → 2020-07-23
Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain NCT01318369	Phase 2	Completed	Radboud University Medical Center	24	2011-10 → 2013-05
A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers NCT01364558	Phase 1	Completed	University of Minnesota	24	2011-02 → 2011-04
Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy NCT01759706	N/A	Completed	Università Vita-Salute San Raffaele	123	2010-10 → 2013-01
Battlefield Acupuncture for Acute/Subacute Back Pain in the Emergency Department NCT03996564	N/A	Completed	San Antonio Military Medical Center	26	2016-02-22 → 2016-12-12
Conscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)NCT03653520	N/A	Completed	Avanti Anesthesia	651	2017-06-28 → 2017-11-04
Diazepam Buccal Film (DBF) - Diastat Rectal Gel (DRG) Crossover Study NCT03953820	Phase 1/2	Completed	Aquestive Therapeutics	31	2019-04-13 → 2019-07-31
Effect of Multimodal Analgesia on Pain With Insertion of Levonorgestrel-releasing IUD NCT02799641	N/A	Completed	TriHealth Inc.	61	2016-07 → 2022-06

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

API Supply Chain5 active DMFs4 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

POLFA TARCHOMINInactiveDIAZEPAM, BULK

DMF 35231979

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

3 letters from Drugs@FDA

Date	Submission	Document
Jan 17, 2023	SUPPL -34	View Letter (PDF)
Feb 9, 2021	SUPPL -33	View Letter (PDF)
Dec 22, 2016	SUPPL -32	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**

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 5, 1990

No patent or exclusivity listings for this strength.