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Details for New Drug Application (NDA): 078449

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NDA 078449 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-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: 078449

Apotex Inc

Pharmacology for NDA: 078449


Suppliers and Packaging for NDA: 078449

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET, EXTENDED RELEASE;ORAL 078449 ANDA Apotex Corp 60505-2634 60505-2634-0 10 BLISTER PACK in 1 CARTON (60505-2634-0) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
TABLET, EXTENDED RELEASE;ORAL 078449 ANDA Apotex Corp 60505-2634 60505-2634-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-2634-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.5MG
Approval Date:Nov 12, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2MG
Approval Date:Nov 12, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength3MG
Approval Date:Nov 12, 2008TE:ABRLD:No

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