Details for New Drug Application (NDA): 091384
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The generic ingredient in RISPERIDONE is risperidone. There are thirty drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 091384
Tradename: | RISPERIDONE |
Applicant: | Amneal Pharms |
Ingredient: | risperidone |
Patents: | 0 |
Suppliers and Packaging for NDA: 091384
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RISPERIDONE | risperidone | SOLUTION;ORAL | 091384 | ANDA | Amneal Pharmaceuticals LLC | 65162-673 | 65162-673-84 | 30 mL in 1 BOTTLE (65162-673-84) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/ML | ||||
Approval Date: | May 25, 2011 | TE: | AA | RLD: | No |
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