Details for New Drug Application (NDA): 210479
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The generic ingredient in ARIPIPRAZOLE is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 210479
Tradename: | ARIPIPRAZOLE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | aripiprazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 210479
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | aripiprazole | SOLUTION;ORAL | 210479 | ANDA | Aurobindo Pharma Limited | 59651-110 | 59651-110-55 | 1 BOTTLE in 1 CARTON (59651-110-55) / 150 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/ML | ||||
Approval Date: | Jan 29, 2019 | TE: | AA | RLD: | No |
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