Details for New Drug Application (NDA): 079059
✉ Email this page to a colleague
The generic ingredient in RISPERIDONE is risperidone. There are thirty drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 079059
Tradename: | RISPERIDONE |
Applicant: | Tris Pharma Inc |
Ingredient: | risperidone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 079059
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RISPERIDONE | risperidone | SOLUTION;ORAL | 079059 | ANDA | Tris Pharma Inc | 27808-002 | 27808-002-01 | 30 mL in 1 BOTTLE, UNIT-DOSE (27808-002-01) |
RISPERIDONE | risperidone | SOLUTION;ORAL | 079059 | ANDA | REMEDYREPACK INC. | 70518-3741 | 70518-3741-0 | 10 CUP, UNIT-DOSE in 1 BOX (70518-3741-0) / 2 mL in 1 CUP, UNIT-DOSE (70518-3741-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/ML | ||||
Approval Date: | Dec 12, 2012 | TE: | AA | RLD: | No |
Complete Access Available with Subscription