Details for New Drug Application (NDA): 074909
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The generic ingredient in ALPRAZOLAM is alprazolam. There are fifteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the alprazolam profile page.
Summary for 074909
Tradename: | ALPRAZOLAM |
Applicant: | Sandoz |
Ingredient: | alprazolam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 074909
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALPRAZOLAM | alprazolam | TABLET;ORAL | 074909 | ANDA | Sandoz Inc | 0781-1089 | 0781-1089-01 | 100 TABLET in 1 BOTTLE (0781-1089-01) |
ALPRAZOLAM | alprazolam | TABLET;ORAL | 074909 | ANDA | Sandoz Inc | 0781-1089 | 0781-1089-05 | 500 TABLET in 1 BOTTLE (0781-1089-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Mar 25, 1998 | TE: | AB | RLD: | No |
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