Details for New Drug Application (NDA): 206383
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NDA 206383 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 206383
| Tradename: | ARIPIPRAZOLE |
| Applicant: | Sciegen Pharms |
| Ingredient: | aripiprazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206383
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 206383 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8375 | 0615-8375-39 | 30 TABLET in 1 BLISTER PACK (0615-8375-39) |
| ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 206383 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8524 | 0615-8524-39 | 30 TABLET in 1 BLISTER PACK (0615-8524-39) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Sep 29, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Sep 29, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Sep 29, 2016 | TE: | AB | RLD: | No | ||||
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