Details for New Drug Application (NDA): 216150
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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 216150
Tradename: | ARIPIPRAZOLE |
Applicant: | Hetero Labs Ltd Iii |
Ingredient: | aripiprazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 216150
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | aripiprazole | SOLUTION;ORAL | 216150 | ANDA | Camber Pharmaceuticals, Inc. | 31722-684 | 31722-684-15 | 1 BOTTLE in 1 CARTON (31722-684-15) / 150 mL in 1 BOTTLE |
ARIPIPRAZOLE | aripiprazole | SOLUTION;ORAL | 216150 | ANDA | NorthStar RxLLC | 72603-445 | 72603-445-01 | 1 BOTTLE in 1 CARTON (72603-445-01) / 150 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/ML | ||||
Approval Date: | Nov 1, 2023 | TE: | AA | RLD: | No |
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