ETHINYL ESTRADIOL; SEGESTERONE ACETATE | N209627 | MAYNE PHARMA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Therapeutics MD, Inc. FDA-2021-P-0293 TherapeuticsMD, Inc. filed this citizen petition requesting that the FDA refrain from approving any Abbreviated New Drug Application referencing Annovera (segesterone acetate and ethinyl estradiol vaginal system), NDA #209627, unless the generic product is qualitatively and quantitatively identical | 505(q) | 2021-03-16 | Denied | Therapeutics MD |
Source: Regulations.gov. FDA citizen petitions matched by application number.