Details for New Drug Application (NDA): 216208
NDA 216208 describes ARIPIPRAZOLE, which is a drug marketed by Mylan, Amneal Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd Iii, Lannett Co Inc, Quagen, Rubicon Research, Vistapharm Llc, Alembic, Aurobindo Pharma, Orbion Pharms, Sciegen Pharms, Square Pharms, Accord Hlthcare, Aiping Pharm Inc, Ajanta Pharma Ltd, Alkem Labs Ltd, Hetero Labs Ltd V, Lupin, Macleods Pharms, Prinston Inc, Rising, Sunshine, Teva Pharms Usa, Torrent, Unichem, and Zydus Pharms, and is included in thirty-seven NDAs. It is available from forty-seven suppliers. Additional details are available on the ARIPIPRAZOLE profile page.
The generic ingredient in ARIPIPRAZOLE is aripiprazole. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
The generic ingredient in ARIPIPRAZOLE is aripiprazole. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 216208
| Tradename: | ARIPIPRAZOLE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | aripiprazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216208
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARIPIPRAZOLE | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 216208 | ANDA | Aurobindo Pharma Limited | 59651-514 | 59651-514-03 | 3 BLISTER PACK in 1 CARTON (59651-514-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
| ARIPIPRAZOLE | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 216208 | ANDA | Aurobindo Pharma Limited | 59651-514 | 59651-514-30 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-514-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG | ||||
| Approval Date: | Feb 18, 2026 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 15MG | ||||
| Approval Date: | Feb 18, 2026 | TE: | RLD: | No | |||||
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