Details for New Drug Application (NDA): 204111
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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 204111
Tradename: | ARIPIPRAZOLE |
Applicant: | Macleods Pharms Ltd |
Ingredient: | aripiprazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 204111
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 204111 | ANDA | Macleods Pharmaceuticals Limited | 33342-122 | 33342-122-07 | 30 TABLET in 1 BOTTLE (33342-122-07) |
ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 204111 | ANDA | Macleods Pharmaceuticals Limited | 33342-122 | 33342-122-11 | 100 TABLET in 1 BOTTLE (33342-122-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Oct 7, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Oct 7, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Oct 7, 2016 | TE: | AB | RLD: | No |
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