DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 078116
NDA 078116 describes RISPERIDONE, which is a drug marketed by Amneal Pharms, Ani Pharms Inc, Apotex Inc, Bio Pharm Inc, Lifestar Pharma, Precision Dose, Silarx Pharms Inc, Taro, Tris Pharma Inc, Vintage, 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 forty-five 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. Forty-seven 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. Forty-seven suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 078116
| Tradename: | RISPERIDONE |
| Applicant: | Sandoz |
| Ingredient: | risperidone |
| Patents: | 0 |
| Therapeutic Class: | Antipsychotics Bipolar Agents |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 078116
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 078116 | ANDA | Sandoz Inc | 0781-5310 | N | 0781-5310-08 |
| RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 078116 | ANDA | Sandoz Inc | 0781-5311 | N | 0781-5311-08 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Dec 22, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 1MG | ||||
| Approval Date: | Dec 22, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 2MG | ||||
| Approval Date: | Dec 22, 2009 | TE: | AB | RLD: | No | ||||
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