Details for New Drug Application (NDA): 078583
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The generic ingredient in ARIPIPRAZOLE is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 078583
Tradename: | ARIPIPRAZOLE |
Applicant: | Apotex |
Ingredient: | aripiprazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 078583
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 078583 | ANDA | Major Pharmaceuticals | 0904-6509 | 0904-6509-04 | 30 BLISTER PACK in 1 CARTON (0904-6509-04) / 1 TABLET in 1 BLISTER PACK |
ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 078583 | ANDA | Major Pharmaceuticals | 0904-6510 | 0904-6510-06 | 50 BLISTER PACK in 1 CARTON (0904-6510-06) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Jul 24, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jul 24, 2015 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jul 24, 2015 | TE: | AB | RLD: | No |
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