Details for New Drug Application (NDA): 078056
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The generic ingredient in ALPRAZOLAM is alprazolam. There are fifteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the alprazolam profile page.
Summary for 078056
Tradename: | ALPRAZOLAM |
Applicant: | Actavis Elizabeth |
Ingredient: | alprazolam |
Patents: | 0 |
Suppliers and Packaging for NDA: 078056
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALPRAZOLAM | alprazolam | TABLET, EXTENDED RELEASE;ORAL | 078056 | ANDA | Actavis Pharma, Inc. | 0228-3083 | 0228-3083-06 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-3083-06) |
ALPRAZOLAM | alprazolam | TABLET, EXTENDED RELEASE;ORAL | 078056 | ANDA | Actavis Pharma, Inc. | 0228-3084 | 0228-3084-06 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-3084-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 0.5MG | ||||
Approval Date: | Feb 13, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1MG | ||||
Approval Date: | Feb 13, 2007 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 2MG | ||||
Approval Date: | Feb 13, 2007 | TE: | AB | RLD: | No |
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