TADALAFIL | N022332 | ELI LILLY CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consultant Services, Inc. FDA-2024-P-5963 Lachman Consultant Services, Inc. filed this suitability petition on behalf of a client requesting that the FDA declare Tadalafil Tablets, 40 mg suitable for submission as an ANDA under Section 505(j)(2)(C) of the FD&C Act, with ADCIRCA (tadalafil) Tablets, 20 mg by Eli Lilly as the reference listed | Suitability | 2025-01-02 | Open | Lachman Consultant Services |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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