Details for New Drug Application (NDA): 090165
NDA 090165 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 090165
| Tradename: | ARIPIPRAZOLE |
| Applicant: | Square Pharms |
| Ingredient: | aripiprazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090165
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARIPIPRAZOLE | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 090165 | ANDA | Viona Pharmaceuticals Inc. | 72578-106 | 72578-106-06 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (72578-106-06) |
| ARIPIPRAZOLE | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 090165 | ANDA | Viona Pharmaceuticals Inc. | 72578-106 | 72578-106-78 | 3 BLISTER PACK in 1 CARTON (72578-106-78) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (72578-106-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG | ||||
| Approval Date: | Aug 28, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 15MG | ||||
| Approval Date: | Aug 28, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 20MG | ||||
| Approval Date: | Aug 28, 2018 | TE: | RLD: | No | |||||
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