Details for New Drug Application (NDA): 077493
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NDA 077493 describes RISPERIDONE, which is a drug marketed by Teva Pharms Usa Inc, Amneal Pharms, Ani Pharms, Aurobindo Pharma Ltd, Chartwell Molecular, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Sciegen Pharms Inc, Taro, Tris Pharma Inc, Wockhardt, Actavis Labs Fl Inc, Chartwell Rx, Dash Pharms, Dr Reddys Labs Ltd, Endo Operations, Jubilant Generics, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Amneal, Apotex Inc, Esjay Pharma, Heritage Pharma Avet, Ipca Labs Ltd, Jubilant Cadista, Prinston Inc, Ratiopharm, Renata, Rising, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc, and is included in forty-six NDAs. It is available from thirty-one suppliers. Additional details are available on the RISPERIDONE profile page.
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.
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 077493
| Tradename: | RISPERIDONE |
| Applicant: | Prinston Inc |
| Ingredient: | risperidone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 077493
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RISPERIDONE | risperidone | TABLET;ORAL | 077493 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8196 | 0615-8196-05 | 15 TABLET in 1 BLISTER PACK (0615-8196-05) |
| RISPERIDONE | risperidone | TABLET;ORAL | 077493 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8196 | 0615-8196-39 | 30 TABLET in 1 BLISTER PACK (0615-8196-39) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
| Approval Date: | Nov 29, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Nov 29, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Nov 29, 2011 | TE: | AB | RLD: | No | ||||
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