Details for New Drug Application (NDA): 211220
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NDA 211220 describes RISPERIDONE, which is a drug marketed by Amneal, Nanomi, Teva Pharms Usa Inc, Amneal Pharms, Ani Pharms, Apozeal Pharms, Aurobindo Pharma Ltd, Chartwell Molecular, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Sun Pharma Canada, Tris Pharma Inc, Wockhardt Bio Ag, Actavis Labs Fl Inc, Chartwell Rx, Jubilant Generics, Natco Pharma Usa, Ph Health, Sandoz, Senores Pharms, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Apotex Inc, Dr Reddys Labs Ltd, 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-eight NDAs. It is available from thirty-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 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 suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 211220
| Tradename: | RISPERIDONE |
| Applicant: | Nanomi |
| Ingredient: | risperidone |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 211220
Suppliers and Packaging for NDA: 211220
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RISPERIDONE | risperidone | POWDER;INTRAMUSCULAR | 211220 | ANDA | Lupin Pharmaceuticals, Inc. | 70748-270 | 70748-270-13 | 1 KIT in 1 BOX (70748-270-13) * 2 mL in 1 VIAL (70748-449-11) * 2 mL in 1 SYRINGE (70748-448-01) |
| RISPERIDONE | risperidone | POWDER;INTRAMUSCULAR | 211220 | ANDA | Lupin Pharmaceuticals, Inc. | 70748-271 | 70748-271-13 | 1 KIT in 1 BOX (70748-271-13) * 2 mL in 1 VIAL (70748-450-11) * 2 mL in 1 SYRINGE (70748-448-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAMUSCULAR | Strength | 25MG/VIAL | ||||
| Approval Date: | Sep 2, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | May 12, 2026 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAMUSCULAR | Strength | 37.5MG/VIAL | ||||
| Approval Date: | Sep 2, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | May 9, 2026 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAMUSCULAR | Strength | 50MG/VIAL | ||||
| Approval Date: | Sep 2, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | May 9, 2026 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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