Details for New Drug Application (NDA): 205363
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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 205363
Tradename: | ARIPIPRAZOLE |
Applicant: | Prinston Inc |
Ingredient: | aripiprazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 205363
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 205363 | ANDA | Solco Healthcare U.S., LLC | 43547-302 | 43547-302-03 | 30 TABLET in 1 BOTTLE (43547-302-03) |
ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 205363 | ANDA | Solco Healthcare U.S., LLC | 43547-302 | 43547-302-09 | 90 TABLET in 1 BOTTLE (43547-302-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Dec 4, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 4, 2017 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 4, 2017 | TE: | AB | RLD: | No |
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