Details for New Drug Application (NDA): 078387
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NDA 078387 describes ALPRAZOLAM, which is a drug marketed by Hikma, Roxane, Actavis Elizabeth, Actavis Labs Fl Inc, Amneal Pharms Ny, Ani Pharms, Apotex Inc, Aurobindo Pharma, Endo Operations, Heritage Pharms Inc, Impax Labs, Impax Labs Inc, Norvium Bioscience, Sandoz Inc, Chartwell Rx, Ivax Sub Teva Pharms, Mylan, Natco, Novitium Pharma, Oxford Pharms, Sandoz, Strides Pharma, Sun Pharm, and Watson Labs, and is included in thirty-six NDAs. It is available from thirty-two suppliers. Additional details are available on the ALPRAZOLAM profile page.
The generic ingredient in ALPRAZOLAM is alprazolam. There are fifteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the alprazolam profile page.
The generic ingredient in ALPRAZOLAM is alprazolam. There are fifteen drug master file entries for this compound. Thirty-six 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 |
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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