Details for New Drug Application (NDA): 202101
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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 202101
Tradename: | ARIPIPRAZOLE |
Applicant: | Alembic |
Ingredient: | aripiprazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 202101
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 202101 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-0100 | 17856-0100-1 | 100 POUCH in 1 BOX, UNIT-DOSE (17856-0100-1) / 1 TABLET in 1 POUCH (17856-0100-2) |
ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 202101 | ANDA | Alembic Pharmaceuticals Limited | 46708-254 | 46708-254-10 | 100 TABLET in 1 CARTON (46708-254-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Apr 28, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Apr 28, 2015 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Apr 28, 2015 | TE: | AB | RLD: | No |
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