Details for New Drug Application (NDA): 214835
NDA 214835 describes RISVAN, which is a drug marketed by Labs Farms Rovi Sa and is included in one NDA. There are fourteen patents protecting this drug. Additional details are available on the RISVAN profile page.
The generic ingredient in RISVAN 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 RISVAN 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 214835
| Tradename: | RISVAN |
| Applicant: | Labs Farms Rovi Sa |
| Ingredient: | risperidone |
| Patents: | 14 |
Medical Subject Heading (MeSH) Categories for 214835
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: | ⤷ Start Trial | Patent Expiration: | May 31, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 31, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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