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-three 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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