ESTROGENS, CONJUGATED | N004782 | WYETH PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Diamond Research Foundation FDA-2026-P-4854 Beth Rosenshein of the Diamond Research Foundation submitted this petition requesting that the FDA require Pfizer to add pharmacokinetic parameters for unconjugated and conjugated estradiol to Table 2 in Section 12.3 of the Full Prescribing Information for Premarin tablets in all dose strengths (0.3 | Other | 2026-05-05 | Open | Diamond Research Foundation |
Suitability Petition from Lachman Consulting Services, Inc. FDA-2026-P-2971 Lachman Consulting Services, Inc. filed this suitability petition under Section 505(j)(2)(C) of the FD&C Act requesting that the FDA declare Conjugated Estrogen Tablets, 0.15 mg suitable for submission as an ANDA based on the reference listed drug PREMARIN Tablets by Wyeth Pharmaceuticals LLC (NDA # | Suitability | 2026-03-24 | Open | Lachman Consulting Services |
Citizen Petition from Pfizer Inc FDA-2018-P-3325 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.
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