CEFTAROLINE FOSAMIL | N200327 | ABBVIE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Qilu Pharma, Inc. (Qilu Pharmaceutical Co., Ltd.) FDA-2014-P-0700 Qilu Pharma, Inc., as the US agent for Qilu Pharmaceutical Co., Ltd., submitted a suitability petition under section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine that new strengths of 200mg/vial and 300mg/vial of Ceftaroline Fosamil for Injection are suit | Other | 2014-05-30 | Open | Qilu Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.