Details for New Drug Application (NDA): 214835
✉ Email this page to a colleague
NDA 214835 describes RISVAN, which is a drug marketed by Labs Farms Rovi Sa and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the RISVAN profile page.
The generic ingredient in RISVAN is risperidone. There are thirty drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the risperidone profile page.
The generic ingredient in RISVAN is risperidone. There are thirty drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 214835
| Tradename: | RISVAN |
| Applicant: | Labs Farms Rovi Sa |
| Ingredient: | risperidone |
| Patents: | 14 |
Suppliers and Packaging for NDA: 214835
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RISVAN | risperidone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 214835 | NDA | Laboratorios Farmaceuticos Rovi, S.A. | 82090-001 | 82090-001-01 | 1 KIT in 1 CARTON (82090-001-01) / 1 POUCH in 1 KIT / 2 SYRINGE in 1 POUCH / 575 mg in 1 SYRINGE |
| RISVAN | risperidone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 214835 | NDA | Laboratorios Farmaceuticos Rovi, S.A. | 82090-003 | 82090-003-01 | 1 KIT in 1 CARTON (82090-003-01) / 1 POUCH in 1 KIT / 2 SYRINGE in 1 POUCH / 766.7 mg in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 75MG | ||||
| Approval Date: | Mar 29, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 29, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | May 31, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | May 31, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Complete Access Available with Subscription
