Details for New Drug Application (NDA): 074342
✉ Email this page to a colleague
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 074342
Tradename: | ALPRAZOLAM |
Applicant: | Actavis Elizabeth |
Ingredient: | alprazolam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 074342
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALPRAZOLAM | alprazolam | TABLET;ORAL | 074342 | ANDA | Actavis Pharma, Inc. | 0228-2027 | 0228-2027-10 | 100 TABLET in 1 BOTTLE (0228-2027-10) |
ALPRAZOLAM | alprazolam | TABLET;ORAL | 074342 | ANDA | Actavis Pharma, Inc. | 0228-2027 | 0228-2027-50 | 500 TABLET in 1 BOTTLE (0228-2027-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
Approval Date: | Oct 31, 1993 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Oct 31, 1993 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Oct 31, 1993 | TE: | AB | RLD: | No |
Complete Access Available with Subscription