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Details for New Drug Application (NDA): 074174

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NDA 074174 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-nine suppliers are listed for this compound. Additional details are available on the alprazolam profile page.

Summary for NDA: 074174

Dava Intl Inc

Pharmacology for NDA: 074174


Suppliers and Packaging for NDA: 074174

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 074174 ANDA Blenheim Pharmacal, Inc. 10544-118 10544-118-30 30 TABLET in 1 BOTTLE (10544-118-30)
TABLET;ORAL 074174 ANDA Blenheim Pharmacal, Inc. 10544-155 10544-155-30 30 TABLET in 1 BOTTLE (10544-155-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Oct 19, 1993TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Oct 19, 1993TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Oct 19, 1993TE:ABRLD:No

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