Details for New Drug Application (NDA): 090839
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The generic ingredient in RISPERIDONE is risperidone. There are thirty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 090839
Tradename: | RISPERIDONE |
Applicant: | Jubilant Generics |
Ingredient: | risperidone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 090839
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 090839 | ANDA | Jubilant Cadista Pharmaceuticals Inc. | 59746-010 | 59746-010-22 | 7 BLISTER PACK in 1 CARTON (59746-010-22) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 090839 | ANDA | Jubilant Cadista Pharmaceuticals Inc. | 59746-010 | 59746-010-32 | 3 BLISTER PACK in 1 CARTON (59746-010-32) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 0.5MG | ||||
Approval Date: | Nov 4, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 1MG | ||||
Approval Date: | Nov 4, 2011 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 2MG | ||||
Approval Date: | Nov 4, 2011 | TE: | AB | RLD: | No |
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