Details for New Drug Application (NDA): 213586
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NDA 213586 describes UZEDY, which is a drug marketed by Teva and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the UZEDY profile page.
The generic ingredient in UZEDY 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 UZEDY 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 213586
| Tradename: | UZEDY |
| Applicant: | Teva |
| Ingredient: | risperidone |
| Patents: | 9 |
Suppliers and Packaging for NDA: 213586
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| UZEDY | risperidone | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 213586 | NDA | Teva Pharmaceuticals USA, Inc. | 51759-305 | 51759-305-10 | 1 SYRINGE, GLASS in 1 CARTON (51759-305-10) / .14 mL in 1 SYRINGE, GLASS |
| UZEDY | risperidone | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 213586 | NDA | Teva Pharmaceuticals USA, Inc. | 51759-305 | 51759-305-11 | 1 SYRINGE, GLASS in 1 CARTON (51759-305-11) / .14 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Strength | 50MG/0.14ML (50MG/0.14ML) | ||||
| Approval Date: | Apr 28, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 28, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 12, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 12, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF SCHIZOPHRENIA | ||||||||
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