Details for New Drug Application (NDA): 218586
NDA 218586 describes RISPERIDONE, which is a drug marketed by Amneal, Nanomi, Teva Pharms Usa Inc, Amneal Pharms, Ani Pharms, Aurobindo Pharma Ltd, Chartwell Molecular, Hikma, Lannett Co Inc, Pharm Assoc, Pharmazone, 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, 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-seven suppliers. Additional details are available on the RISPERIDONE profile page.
The generic ingredient in RISPERIDONE is risperidone. There is one drug master file entry 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 is one drug master file entry for this compound. Forty suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 218586
| Tradename: | RISPERIDONE |
| Applicant: | Amneal |
| Ingredient: | risperidone |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 218586
Suppliers and Packaging for NDA: 218586
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RISPERIDONE | risperidone | POWDER;INTRAMUSCULAR | 218586 | ANDA | Amneal Pharmaceuticals LLC | 70121-2625 | 70121-2625-5 | 1 KIT in 1 CARTON (70121-2625-5) * 2 mL in 1 VIAL (70121-1350-1) * 2 mL in 1 SYRINGE (70121-2624-2) |
| RISPERIDONE | risperidone | POWDER;INTRAMUSCULAR | 218586 | ANDA | Amneal Pharmaceuticals LLC | 70121-2626 | 70121-2626-5 | 1 KIT in 1 CARTON (70121-2626-5) * 2 mL in 1 SYRINGE (70121-2624-2) * 2 mL in 1 VIAL (70121-1351-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAMUSCULAR | Strength | 12.5MG/VIAL | ||||
| Approval Date: | Sep 2, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAMUSCULAR | Strength | 25MG/VIAL | ||||
| Approval Date: | Sep 2, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAMUSCULAR | Strength | 37.5MG/VIAL | ||||
| Approval Date: | Sep 2, 2025 | TE: | AB | RLD: | No | ||||
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