Details for New Drug Application (NDA): 207105
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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 207105
Tradename: | ARIPIPRAZOLE |
Applicant: | Alkem Labs Ltd |
Ingredient: | aripiprazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 207105
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 207105 | ANDA | A-S Medication Solutions | 50090-4665 | 50090-4665-0 | 30 TABLET in 1 BOTTLE (50090-4665-0) |
ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 207105 | ANDA | A-S Medication Solutions | 50090-4665 | 50090-4665-1 | 90 TABLET in 1 BOTTLE (50090-4665-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Feb 21, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Feb 21, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Feb 21, 2019 | TE: | AB | RLD: | No |
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