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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071322

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NDA 071322 describes DIAZEPAM, which is a drug marketed by Lannett Holdings Inc, Abraxis Pharm, Hospira, Marsam Pharms Llc, Parenta Pharms, Us Army, Warner Chilcott, Watson Labs, Watson Labs Inc, West-ward Pharms Int, Actavis Elizabeth, Barr, Dava Pharms Inc, Duramed Pharms Barr, Ferndale Labs, Halsey, Ivax Sub Teva Pharms, Martec Usa Llc, Mayne Pharma, Mylan, Pioneer Pharms, Roxane, Teva Pharms, Upsher-smith Labs, Vintage Pharms, and Virtus Pharms, and is included in seventy-one NDAs. It is available from thirty-six suppliers. Additional details are available on the DIAZEPAM profile page.

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

Summary for 071322

Tradename:	DIAZEPAM
Applicant:	Ivax Sub Teva Pharms
Ingredient:	diazepam
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 071322

Ingredient-type	Benzodiazepines

Medical Subject Heading (MeSH) Categories for 071322

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

Suppliers and Packaging for NDA: 071322

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIAZEPAM	diazepam	TABLET;ORAL	071322	ANDA	Teva Pharmaceuticals USA, Inc.	0172-3927	N	0172-3927-70
DIAZEPAM	diazepam	TABLET;ORAL	071322	ANDA	Teva Pharmaceuticals USA, Inc.	0172-3927	N	0172-3927-80

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Dec 10, 1986	TE:	AB	RLD:	No

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