Details for New Drug Application (NDA): 206383
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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 206383
Tradename: | ARIPIPRAZOLE |
Applicant: | Sciegen Pharms Inc |
Ingredient: | aripiprazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 206383
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 206383 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8375 | 0615-8375-39 | 30 TABLET in 1 BLISTER PACK (0615-8375-39) |
ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 206383 | ANDA | Dr.Reddy?s Laboratories Inc | 43598-554 | 43598-554-05 | 500 TABLET in 1 BOTTLE (43598-554-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Sep 29, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Sep 29, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Sep 29, 2016 | TE: | AB | RLD: | No |
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