Details for New Drug Application (NDA): 078387
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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 078387
Tradename: | ALPRAZOLAM |
Applicant: | Amneal Pharms Ny |
Ingredient: | alprazolam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 078387
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALPRAZOLAM | alprazolam | TABLET, EXTENDED RELEASE;ORAL | 078387 | ANDA | Amneal Pharmaceuticals LLC | 65162-809 | 65162-809-03 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-809-03) |
ALPRAZOLAM | alprazolam | TABLET, EXTENDED RELEASE;ORAL | 078387 | ANDA | Amneal Pharmaceuticals LLC | 65162-809 | 65162-809-06 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-809-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 0.5MG | ||||
Approval Date: | May 30, 2008 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1MG | ||||
Approval Date: | May 30, 2008 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 2MG | ||||
Approval Date: | May 30, 2008 | TE: | AB | RLD: | No |
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