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Details for New Drug Application (NDA): 078561

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NDA 078561 describes ALPRAZOLAM, which is a drug marketed by Sandoz, West-ward Pharms Int, Roxane, Mylan, Ani Pharms Inc, Natco Pharma Ltd, Apotex Inc, Vintage Pharms, Actavis Elizabeth, Aurobindo Pharma Ltd, Mylan Pharms Inc, Watson Labs, Impax Labs, Anchen Pharms, Aurobindo Pharma Usa, Dava Intl Inc, Sandoz Inc, Sun Pharma Global, Amneal Pharms Ny, Par Pharm, Heritage Pharms Inc, Vintage, Ivax Sub Teva Pharms, Corepharma, and Actavis Labs Fl Inc, and is included in thirty-five NDAs. It is available from fifty-five 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. Fifty-seven suppliers are listed for this compound. Additional details are available on the alprazolam profile page.

Summary for NDA: 078561

Actavis Elizabeth
Formulation / Manufacturing:see details

Pharmacology for NDA: 078561


Suppliers and Packaging for NDA: 078561

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET, ORALLY DISINTEGRATING;ORAL 078561 ANDA Actavis Pharma, Inc. 0228-4019 0228-4019-11 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0228-4019-11)
TABLET, ORALLY DISINTEGRATING;ORAL 078561 ANDA Actavis Pharma, Inc. 0228-4022 0228-4022-11 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0228-4022-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.25MG
Approval Date:Mar 16, 2010TE:ABRLD:No

Summary for product number 002

Approval Date:Mar 16, 2010TE:ABRLD:No

Summary for product number 003

Approval Date:Mar 16, 2010TE:ABRLD:No

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