Last Updated: September 24, 2026

Details for New Drug Application (NDA): 218422

✉ Email this page to a colleague

« Back to Dashboard

NDA 218422 describes DIAZEPAM, which is a drug marketed by Chartwell Molecular, Navinta Llc, Novel Labs Inc, Abraxis Pharm, Alembic, Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Galenicum Hlth, Hikma, Hospira, Long Grove Pharms, Lupin, Marsam Pharms Llc, Parenta Pharms, Regcon Holdings, Us Army, Warner Chilcott, Watson Labs, Watson Labs Inc, Actavis Elizabeth, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Dr Reddys Labs Sa, Duramed Pharms Barr, Ferndale Labs, Halsey, Ivax Sub Teva Pharms, Martec Usa Llc, Mylan, Nuvo Pharm, Ph Health, Pioneer Pharms, Roxane, Strides Pharma Intl, Teva Pharms, and Virtus, and is included in eighty-three NDAs. It is available from forty-six suppliers. Additional details are available on the DIAZEPAM profile page.

The generic ingredient in DIAZEPAM is diazepam. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the diazepam profile page.

Summary for 218422

Tradename:	DIAZEPAM
Applicant:	Dr Reddys
Ingredient:	diazepam
Patents:	0

Pharmacology for NDA: 218422

Medical Subject Heading (MeSH) Categories for 218422

Adjuvants, Anesthesia
Anesthetics, Intravenous
Anti-Anxiety Agents
Anticonvulsants
Antiemetics
GABA Modulators
Hypnotics and Sedatives
Muscle Relaxants, Central

Suppliers and Packaging for NDA: 218422

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIAZEPAM	diazepam	INJECTABLE;INJECTION	218422	ANDA	Dr. Reddy's Laboratories Inc	43598-106	43598-106-58	10 SYRINGE, GLASS in 1 CARTON (43598-106-58) / 2 mL in 1 SYRINGE, GLASS (43598-106-11)
DIAZEPAM	diazepam	INJECTABLE;INJECTION	218422	ANDA	Dr. Reddy's Laboratories Inc	43598-106	43598-106-10	10 SYRINGE, GLASS in 1 CARTON (43598-106-10) / 2 mL in 1 SYRINGE, GLASS (43598-106-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/2ML (5MG/ML)
Approval Date:	Jul 18, 2024	TE:	AP	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.