Details for New Drug Application (NDA): 078071
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NDA 078071 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, Heritage Pharma Avet, Ipca Labs Ltd, Jubilant Cadista, Novitium Pharma, 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-three 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-eight 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-eight 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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