Details for New Drug Application (NDA): 203906
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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 203906
Tradename: | ARIPIPRAZOLE |
Applicant: | Amneal Pharms |
Ingredient: | aripiprazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 203906
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | aripiprazole | SOLUTION;ORAL | 203906 | ANDA | Amneal Pharmaceuticals LLC | 65162-893 | 65162-893-74 | 1 BOTTLE in 1 CARTON (65162-893-74) / 150 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/ML | ||||
Approval Date: | Aug 14, 2015 | TE: | AA | RLD: | No |
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