ESTROGENS, CONJUGATED | A214023 | NOVAST LABORATORIES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Diamond Research Foundation FDA-2025-P-7111 · 7 docket documents Beth Rosenshein of the Diamond Research Foundation submitted a citizen petition requesting that the FDA update the Indications and Usage section of the Full Prescribing Information for Premarin tablets to include information about equilin, a major component comprising 22-30% of the drug that may fun | Other | 2025-12-17 | Open | Diamond Research Foundation |
Citizen Petition from Pfizer Inc FDA-2018-P-3325 · 18 docket documents Pfizer Inc. filed this citizen petition under 21 USC 355 and 21 CFR 10.30 regarding any abbreviated new drug application for a generic version of Premarin (conjugated estrogens), requesting that FDA develop new guidance for assessing sameness of conjugated estrogens products using a method capable o | 505(q) | 2018-08-30 | Denied | Pfizer Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$5.74
per ea
Lowest NADAC/Unit
$5.70
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 50742039101CONJUGATED ESTROGENS 1.25 MG TB | $5.74 | EA | Generic | — | 2026-06-17 |
| 50742039001CONJUGATED ESTROGENS 0.9 MG TB | $5.70 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Code | Date | Status |
|---|---|---|
| CGT | Apr 15, 2026 | Expired |