Details for New Drug Application (NDA): 216351
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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 216351
Tradename: | ARIPIPRAZOLE |
Applicant: | Rubicon |
Ingredient: | aripiprazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 216351
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | aripiprazole | SOLUTION;ORAL | 216351 | ANDA | Advagen Pharma Ltd | 72888-100 | 72888-100-20 | 1 BOTTLE in 1 CARTON (72888-100-20) / 150 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/ML | ||||
Approval Date: | Oct 27, 2022 | TE: | AA | RLD: | No |
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