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Details for New Drug Application (NDA): 202547
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NDA 202547 describes ARIPIPRAZOLE, which is a drug marketed by Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Lannett Co Inc, Vistapharm, Alembic Pharms Ltd, Orchid Hlthcare, Sciegen Pharms Inc, Zydus Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Alkem Labs Ltd, Boscogen, Hetero Labs Ltd V, Macleods Pharms Ltd, Mylan, Prinston Inc, Teva Pharms Usa, and Torrent, and is included in twenty-eight NDAs. It is available from forty-one 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-three 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-three suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 202547
| Tradename: | ARIPIPRAZOLE |
| Applicant: | Orchid Hlthcare |
| Ingredient: | aripiprazole |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 202547
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARIPIPRAZOLE | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 202547 | ANDA | OrchidPharma Inc | 42043-400 | 42043-400-03 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (42043-400-03) |
| ARIPIPRAZOLE | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 202547 | ANDA | OrchidPharma Inc | 42043-401 | 42043-401-03 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (42043-401-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG | ||||
| Approval Date: | Dec 11, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 15MG | ||||
| Approval Date: | Dec 11, 2017 | TE: | AB | RLD: | No | ||||
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