DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 090839
NDA 090839 describes RISPERIDONE, which is a drug marketed by Amneal Pharms, Ani Pharms Inc, Apotex Inc, Bio Pharm Inc, Lannett Co Inc, Lifestar Pharma, Precision Dose, Taro, Tris Pharma Inc, West-ward Pharms Int, Wockhardt, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Jubilant Generics, Mylan Pharms Inc, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Teva, Zydus Pharms Usa, Ajanta Pharma Ltd, Aurobindo Pharma, Chartwell Molecular, Jubilant Cadista, Mylan, Oxford Pharms, Pliva Hrvatska Doo, Prinston Inc, Ratiopharm, Renata, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc, and is included in forty-four NDAs. It is available from fifty-four 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. Fifty-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. Fifty-six 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 |
| Therapeutic Class: | Antipsychotics Bipolar Agents |
| 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 | N | 59746-010-22 |
| RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 090839 | ANDA | Jubilant Cadista Pharmaceuticals Inc. | 59746-010 | N | 59746-010-32 |
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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