Details for New Drug Application (NDA): 207240
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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 207240
Tradename: | ARIPIPRAZOLE |
Applicant: | Sciegen Pharms Inc |
Ingredient: | aripiprazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 207240
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 207240 | ANDA | Dr. Reddy's Laboratories Inc | 43598-733 | 43598-733-30 | 30 TABLET in 1 BOTTLE (43598-733-30) |
ARIPIPRAZOLE | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 207240 | ANDA | Dr. Reddy's Laboratories Inc | 43598-734 | 43598-734-30 | 30 TABLET in 1 BOTTLE (43598-734-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG | ||||
Approval Date: | Apr 18, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 15MG | ||||
Approval Date: | Apr 18, 2018 | TE: | AB | RLD: | No |
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