SERTRALINE HYDROCHLORIDE | N215133 | ALMATICA PHARMA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consulting Services, Inc. FDA-2024-P-3567 Lachman Consulting Services, Inc. filed this suitability petition on behalf of a client requesting that the FDA declare Sertraline Capsules in 25 mg, 50 mg, and 100 mg strengths suitable for submission as an ANDA under Section 505(j)(2)(C) of the FD&C Act, citing Sertraline Capsules 150 mg and 200 m | Suitability | 2024-07-30 | Open | Lachman Consulting Services |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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