Details for New Drug Application (NDA): 206174
✉ Email this page to a colleague
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 206174
Tradename: | ARIPIPRAZOLE |
Applicant: | Ajanta Pharma Ltd |
Ingredient: | aripiprazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 206174
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 206174 | ANDA | Ajanta Pharma USA Inc. | 27241-051 | 27241-051-03 | 30 TABLET in 1 BOTTLE (27241-051-03) |
ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 206174 | ANDA | Ajanta Pharma USA Inc. | 27241-051 | 27241-051-08 | 500 TABLET in 1 BOTTLE (27241-051-08) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Sep 12, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Sep 12, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Sep 12, 2016 | TE: | AB | RLD: | No |
Complete Access Available with Subscription