Details for New Drug Application (NDA): 078071
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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 078071
Tradename: | RISPERIDONE |
Applicant: | Amneal |
Ingredient: | risperidone |
Patents: | 0 |
Suppliers and Packaging for NDA: 078071
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RISPERIDONE | risperidone | TABLET;ORAL | 078071 | ANDA | AvKARE | 42291-908 | 42291-908-60 | 60 TABLET in 1 BOTTLE (42291-908-60) |
RISPERIDONE | risperidone | TABLET;ORAL | 078071 | ANDA | AvKARE | 42291-908 | 42291-908-50 | 500 TABLET in 1 BOTTLE (42291-908-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
Approval Date: | Jun 17, 2009 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Jun 17, 2009 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Jun 17, 2009 | TE: | AB | RLD: | No |
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