Details for New Drug Application (NDA): 205064
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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 205064
Tradename: | ARIPIPRAZOLE |
Applicant: | Hetero Labs Ltd V |
Ingredient: | aripiprazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 205064
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 205064 | ANDA | NorthStar RxLLC | 16714-141 | 16714-141-01 | 30 TABLET in 1 BOTTLE (16714-141-01) |
ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 205064 | ANDA | NorthStar RxLLC | 16714-142 | 16714-142-01 | 30 TABLET in 1 BOTTLE (16714-142-01) |
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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