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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 074112


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NDA 074112 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-three 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-seven suppliers are listed for this compound. Additional details are available on the alprazolam profile page.
Summary for 074112
Tradename:ALPRAZOLAM
Applicant:Sandoz
Ingredient:alprazolam
Patents:0
Pharmacology for NDA: 074112
Medical Subject Heading (MeSH) Categories for 074112
Suppliers and Packaging for NDA: 074112
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALPRAZOLAM alprazolam TABLET;ORAL 074112 ANDA Sandoz Inc 0781-1061 0781-1061-01 100 TABLET in 1 BOTTLE (0781-1061-01)
ALPRAZOLAM alprazolam TABLET;ORAL 074112 ANDA Sandoz Inc 0781-1061 0781-1061-05 500 TABLET in 1 BOTTLE (0781-1061-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Dec 29, 1995TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Dec 29, 1995TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Dec 29, 1995TE:ABRLD:No

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