Details for New Drug Application (NDA): 078561
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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 078561
Tradename: | ALPRAZOLAM |
Applicant: | Actavis Elizabeth |
Ingredient: | alprazolam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 078561
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALPRAZOLAM | alprazolam | TABLET, ORALLY DISINTEGRATING;ORAL | 078561 | ANDA | Actavis Pharma, Inc. | 0228-4019 | 0228-4019-11 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0228-4019-11) |
ALPRAZOLAM | alprazolam | TABLET, ORALLY DISINTEGRATING;ORAL | 078561 | ANDA | Actavis Pharma, Inc. | 0228-4022 | 0228-4022-11 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0228-4022-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 0.25MG | ||||
Approval Date: | Mar 16, 2010 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 0.5MG | ||||
Approval Date: | Mar 16, 2010 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 1MG | ||||
Approval Date: | Mar 16, 2010 | TE: | AB | RLD: | No |
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