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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 074909

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NDA 074909 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 074909

Tradename:	ALPRAZOLAM
Applicant:	Sandoz
Ingredient:	alprazolam
Patents:	0

Pharmacology for NDA: 074909

Medical Subject Heading (MeSH) Categories for 074909

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 074909

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALPRAZOLAM	alprazolam	TABLET;ORAL	074909	ANDA	Sandoz Inc	0781-1089	0781-1089-01	100 TABLET in 1 BOTTLE (0781-1089-01)
ALPRAZOLAM	alprazolam	TABLET;ORAL	074909	ANDA	Sandoz Inc	0781-1089	0781-1089-05	500 TABLET in 1 BOTTLE (0781-1089-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Mar 25, 1998	TE:	AB	RLD:	No

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