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, Anchen Pharms, Ani Pharms, Apotex Inc, Aurobindo Pharma, Heritage Pharms Inc, Impax Labs, Impax Labs Inc, Mylan, Sandoz Inc, Vintage Pharms, Par Pharm, Breckenridge, Ivax Sub Teva Pharms, Mylan Pharms Inc, Natco, Novitium Pharma, Oxford Pharms, Sandoz, Strides Pharma, Sun Pharm, and Watson Labs, and is included in thirty-six NDAs. It is available from twenty-seven 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 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 suppliers are listed for this compound. Additional details are available on the alprazolam profile page.
Summary for 078088
| Tradename: | ALPRAZOLAM |
| Applicant: | Par Pharm |
| Ingredient: | alprazolam |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
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 | Par Pharmaceutical, 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 | Par Pharmaceutical, 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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