SERTRALINE HYDROCHLORIDE | N019839 | VIATRIS SPECIALTY LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consulting Services, Inc. FDA-2025-P-3576 Lachman Consulting Services, Inc., on behalf of a client, filed this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Sertraline Hydrochloride Tablets, 12.5 mg suitable for submission as an Abbreviated New Drug Applicati | Suitability | 2025-09-05 | Open | Lachman Consulting Services |
Suitability Petition from Premier Research Consulting, LLC FDA-2025-P-2590 Premier Research Consulting, LLC filed this ANDA Suitability Petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA confirmation that Sertraline Hydrochloride Tablets at 75 mg strength is suitable for submission as a supplemental ANDA, with the 75 mg dos | Suitability | 2025-07-23 | Open | Premier Research Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.