Details for New Drug Application (NDA): 203025
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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 203025
Tradename: | ARIPIPRAZOLE |
Applicant: | Unichem |
Ingredient: | aripiprazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 203025
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 203025 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-175 | 29300-175-01 | 100 TABLET in 1 BOTTLE, PLASTIC (29300-175-01) |
ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 203025 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-175 | 29300-175-05 | 500 TABLET in 1 BOTTLE, PLASTIC (29300-175-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Dec 1, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 1, 2021 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 1, 2021 | TE: | AB | RLD: | No |
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