ETHINYL ESTRADIOL; SEGESTERONE ACETATE | N209627 | MAYNE PHARMA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Therapeutics MD, Inc. FDA-2021-P-0293 · 6 docket documents 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 | Partially Denied | Therapeutics MD, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$2316.51
per ea
Lowest NADAC/Unit
$2316.51
per ea
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 68308075201ANNOVERA VAGINAL RING | $2316.51 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.