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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 074312


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NDA 074312 describes ALPRAZOLAM, which is a drug marketed by Hikma, Roxane, Actavis Elizabeth, Actavis Labs Fl Inc, Amneal Pharms Ny, Ani Pharms, Apotex Inc, Aurobindo Pharma, Endo Operations, Heritage Pharms Inc, Impax Labs, Impax Labs Inc, Norvium Bioscience, Sandoz Inc, Chartwell Rx, Ivax Sub Teva Pharms, Mylan, Natco, Novitium Pharma, Oxford Pharms, Sandoz, Strides Pharma, Sun Pharm, and Watson Labs, and is included in thirty-six NDAs. It is available from thirty-two 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. Thirty-six suppliers are listed for this compound. Additional details are available on the alprazolam profile page.
Summary for 074312
Tradename:ALPRAZOLAM
Applicant:Hikma
Ingredient:alprazolam
Patents:0
Pharmacology for NDA: 074312
Medical Subject Heading (MeSH) Categories for 074312
Suppliers and Packaging for NDA: 074312
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALPRAZOLAM alprazolam CONCENTRATE;ORAL 074312 ANDA Hikma Pharmaceuticals USA Inc. 0054-3068 0054-3068-44 1 BOTTLE in 1 CONTAINER (0054-3068-44) / 30 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrength1MG/ML
Approval Date:Oct 31, 1993TE:RLD:No

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