Details for New Drug Application (NDA): 074312
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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 074312
Tradename: | ALPRAZOLAM |
Applicant: | Hikma |
Ingredient: | alprazolam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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: | RX | Dosage: | CONCENTRATE;ORAL | Strength | 1MG/ML | ||||
Approval Date: | Oct 31, 1993 | TE: | RLD: | No |
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