You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 074456

✉ Email this page to a colleague

« Back to Dashboard

NDA 074456 describes ALPRAZOLAM, which is a drug marketed by Hikma, Roxane, Actavis Elizabeth, Actavis Labs Fl Inc, Amneal Pharms Ny, Ani Pharms, Apotex Inc, Aurobindo Pharma, Heritage Pharms Inc, Impax Labs, Impax Labs Inc, Ph Health, Pharmobedient, Sandoz Inc, Chartwell Rx, Ivax Sub Teva Pharms, Mylan, Natco, Novitium Pharma, Oxford Pharms, Sandoz, Strides Pharma Intl, Sun Pharm, and Watson Labs, and is included in thirty-six NDAs. It is available from thirty suppliers. Additional details are available on the ALPRAZOLAM profile page.

The generic ingredient in ALPRAZOLAM is alprazolam. There are fifteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the alprazolam profile page.

Summary for 074456

Tradename:	ALPRAZOLAM
Applicant:	Watson Labs
Ingredient:	alprazolam
Patents:	0

Medical Subject Heading (MeSH) Categories for 074456

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.25MG
Approval Date:	Aug 31, 1995	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Aug 31, 1995	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Aug 31, 1995	TE:		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.