Details for New Drug Application (NDA): 078088
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NDA 078088 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-three 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-seven 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-seven suppliers are listed for this compound. Additional details are available on the alprazolam profile page.
Summary for 078088
| Tradename: | ALPRAZOLAM |
| Applicant: | Endo Operations |
| Ingredient: | alprazolam |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078088
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALPRAZOLAM | alprazolam | TABLET, ORALLY DISINTEGRATING;ORAL | 078088 | ANDA | Endo USA, Inc. | 49884-110 | 49884-110-74 | 10 BLISTER PACK in 1 CARTON (49884-110-74) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
| ALPRAZOLAM | alprazolam | TABLET, ORALLY DISINTEGRATING;ORAL | 078088 | ANDA | Endo USA, Inc. | 49884-111 | 49884-111-74 | 10 BLISTER PACK in 1 CARTON (49884-111-74) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 0.25MG | ||||
| Approval Date: | Jan 9, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Jan 9, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 1MG | ||||
| Approval Date: | Jan 9, 2009 | TE: | AB | RLD: | No | ||||
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