Details for New Drug Application (NDA): 076904
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The generic ingredient in RISPERIDONE is risperidone. There are thirty drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 076904
Tradename: | RISPERIDONE |
Applicant: | Hikma |
Ingredient: | risperidone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 076904
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RISPERIDONE | risperidone | SOLUTION;ORAL | 076904 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0063 | 0054-0063-44 | 30 mL in 1 BOTTLE (0054-0063-44) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/ML | ||||
Approval Date: | Jul 29, 2009 | TE: | AA | RLD: | No |
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