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Last Updated: April 14, 2021

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Details for New Drug Application (NDA): 074342

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NDA 074342 describes ALPRAZOLAM, which is a drug marketed by Hikma, Roxane, Actavis Elizabeth, Actavis Labs Fl Inc, Amneal Pharms Ny, Anchen Pharms, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Heritage Pharms Inc, Impax Labs, Impax Labs Inc, Mylan, Sandoz Inc, Vintage Pharms, Par Pharm, Breckenridge, Ivax Sub Teva Pharms, Mylan Pharms Inc, Natco Pharma Ltd, Novitium Pharma, Oxford Pharms, Sandoz, Sun Pharm, and Watson Labs, and is included in thirty-six NDAs. It is available from thirty-eight 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. Forty suppliers are listed for this compound. Additional details are available on the alprazolam profile page.
Summary for 074342
Tradename:ALPRAZOLAM
Applicant:Actavis Elizabeth
Ingredient:alprazolam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074342
Medical Subject Heading (MeSH) Categories for 074342
Suppliers and Packaging for NDA: 074342
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALPRAZOLAM alprazolam TABLET;ORAL 074342 ANDA Actavis Pharma, Inc. 0228-2027 0228-2027-10 100 TABLET in 1 BOTTLE (0228-2027-10)
ALPRAZOLAM alprazolam TABLET;ORAL 074342 ANDA Actavis Pharma, Inc. 0228-2027 0228-2027-50 500 TABLET in 1 BOTTLE (0228-2027-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Oct 31, 1993TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Oct 31, 1993TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Oct 31, 1993TE:ABRLD:No

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