ESTRADIOL | A086069 | ABBVIE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consulting Services, Inc. FDA-2024-P-3905 Lachman Consulting Services, Inc. filed this suitability petition on behalf of a client under FD&C Act Section 505(j)(2)(C) requesting that FDA declare Estradiol Vaginal Inserts in 1 g and 2 g strengths suitable for submission as an ANDA, based on the reference listed drug Estrace Vaginal Cream 0.01 | Suitability | 2024-08-16 | Open | Lachman Consulting Services |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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