FLUTICASONE PROPIONATE | A077168 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from BF Innovation Inc on behalf of Bright Future Pharmaceut... FDA-2018-P-3746 BF Innovation Inc., on behalf of Bright Future Pharmaceutical Laboratories Limited, submitted a citizen petition requesting that the FDA designate Fluticasone Propionate Ointment 0.005% (Application No. A076668) by Perrigo New York Inc. as an additional Reference Standard under Section 505(j) of the | 505(q) | 2018-10-03 | Open | BF Innovation Inc on behalf of Bright Future Pharmaceutical Laboratories Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.
Cosette Pharmaceuticals' ownership or legal entity name for fluticasone propionate (NDA 077168) changed from "Cosette" to "Cosette Pharms NC" in FDA records.
Old: COSETTE
New: COSETTE PHARMS NC
Cosette Pharmaceuticals updated its legal entity name from Cosette Pharmaceuticals Inc to Cosette Pharmaceuticals NC Laboratories LLC for the fluticasone propionate NDA 077168.
Old: COSETTE PHARMACEUTICALS INC
New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC