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Details for New Drug Application (NDA): 078442

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NDA 078442 describes ALPRAZOLAM, which is a drug marketed by Sandoz, 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-six 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-eight suppliers are listed for this compound. Additional details are available on the alprazolam profile page.

Summary for NDA: 078442

Tradename:
ALPRAZOLAM
Applicant:
Vintage Pharms
Ingredient:
alprazolam
Patents:0
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength0.5MG
Approval Date:Oct 15, 2007TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength1MG
Approval Date:Oct 15, 2007TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength2MG
Approval Date:Oct 15, 2007TE:RLD:No


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