ESTRADIOL | N020323 | SANDOZ INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from TherapeuticsMD, Inc. FDA-2018-P-4714 TherapeuticsMD, Inc. filed this citizen petition under 21 CFR 10.30 and 10.31 requesting that the FDA refrain from approving any abbreviated new drug application referencing Imvexxy (estradiol vaginal inserts), NDA 208564, unless the ANDA sponsor provides bioequivalence data meeting specified requir | 505(q) | 2018-12-12 | Partially Denied | TherapeuticsMD |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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