NICARDIPINE HYDROCHLORIDE | N020005 | CHIESI USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Jubilant Generics FDA-2017-P-2660 Jubilant Generics Ltd. filed this citizen petition on April 27, 2017 pursuant to section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that the discontinuation of CARDENE SR (Nicardipine Hydrochloride Extended Release Capsules, NDA 020005) was not for safety | 505(q) | 2017-04-28 | Open | Jubilant Generics |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.