Details for New Drug Application (NDA): 090165
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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 090165
Tradename: | ARIPIPRAZOLE |
Applicant: | Square Pharms |
Ingredient: | aripiprazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 090165
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 090165 | ANDA | Viona Pharmaceuticals Inc. | 72578-106 | 72578-106-06 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (72578-106-06) |
ARIPIPRAZOLE | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 090165 | ANDA | Viona Pharmaceuticals Inc. | 72578-106 | 72578-106-78 | 3 BLISTER PACK in 1 CARTON (72578-106-78) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (72578-106-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG | ||||
Approval Date: | Aug 28, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 15MG | ||||
Approval Date: | Aug 28, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 20MG | ||||
Approval Date: | Aug 28, 2018 | TE: | RLD: | No |
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