Details for New Drug Application (NDA): 078583
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NDA 078583 describes ARIPIPRAZOLE, which is a drug marketed by Amneal Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd Iii, Lannett Co Inc, Rubicon, Vistapharm, Alembic, Orbion Pharms, Sciegen Pharms Inc, Square Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Alkem Labs Ltd, Aurobindo Pharma, Breckenridge, Hetero Labs Ltd V, Lupin, Macleods Pharms Ltd, Norvium Bioscience, Prinston Inc, Sunshine, Teva Pharms Usa, Torrent, Unichem, and Zydus Pharms, and is included in thirty-four NDAs. It is available from forty-five suppliers. Additional details are available on the ARIPIPRAZOLE profile page.
The generic ingredient in ARIPIPRAZOLE is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
The generic ingredient in ARIPIPRAZOLE is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 078583
| Tradename: | ARIPIPRAZOLE |
| Applicant: | Apotex |
| Ingredient: | aripiprazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078583
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 078583 | ANDA | Major Pharmaceuticals | 0904-6509 | 0904-6509-04 | 30 BLISTER PACK in 1 CARTON (0904-6509-04) / 1 TABLET in 1 BLISTER PACK |
| ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 078583 | ANDA | Major Pharmaceuticals | 0904-6510 | 0904-6510-06 | 50 BLISTER PACK in 1 CARTON (0904-6510-06) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Jul 24, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jul 24, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jul 24, 2015 | TE: | AB | RLD: | No | ||||
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