DESLORATADINE | N021312 | ORGANON LLC A SUB OF ORGANON AND CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consulting Services, Inc. FDA-2026-P-4918 · 7 docket documents Lachman Consulting Services, Inc., on behalf of a client, filed this suitability petition under Section 505(j)(2)(C) of the FD&C Act requesting FDA approval to declare Desloratadine Tablets, 2.5 mg suitable for submission as an ANDA with a change in dosage form from the reference listed drug CLARINE | Suitability | 2026-05-06 | Open | Lachman Consulting Services, Inc. |
Citizens Petition from WellPoint Health Networks FDA-2002-P-0519 · 5 docket documents WellPoint Health Networks, filed by Chief Pharmacy Officer Robert Seidman, submitted this citizen petition under 21 CFR 10.30 requesting that the FDA exempt desloratadine (Clarinex) from prescription-only requirements and approve it for over-the-counter status, arguing that desloratadine has a safet | Other | 2013-03-12 | Withdrawn | WellPoint Health Networks |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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