DESLORATADINE | N021165 | ORGANON LLC A SUB OF ORGANON AND CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consulting Services, Inc. FDA-2025-P-5583 · 9 docket documents Lachman Consulting Services, Inc. filed this suitability petition on behalf of a client requesting that the FDA declare Desloratadine Tablets, 2.5 mg suitable for submission as an ANDA under section 505(j)(2)(C) of the FD&C Act, with CLARINEX Tablets, 5 mg (NDA #021165) as the reference listed drug. | Suitability | 2025-10-24 | Denied | 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requirements and approve it for over-the-counter status, arguing that desloratadine has a safet | Other | 2013-03-12 | Withdrawn | WellPoint Health Networks |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.
Highest NADAC/Unit
$8.85
per ea
Lowest NADAC/Unit
$8.85
per ea
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 78206018801CLARINEX 5 MG TABLET | $8.85 | EA | Brand | $0.2611 | 2026-02-18 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.