FELODIPINE | A090365 | GLENMARK PHARMACEUTICALS LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Mutual Pharmaceutical Company, Inc. FDA-2007-P-0235 Mutual Pharmaceutical Company, Inc. filed this citizen petition requesting that the FDA require the reference listed drug sponsor to generate confirmatory in vitro data on felodipine's metabolism by CYP2C8 and inhibition of CYP2C9, incorporate this information into labeling for Felodipine Extended-R | 505(q) | 2008-04-21 | Partially Denied | Mutual Pharmaceutical Company |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.