DEXCHLORPHENIRAMINE MALEATE | A202520 | PHARMOBEDIENT CONSULTING LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2026-P-7181 · 7 docket documents Senores Pharmaceuticals, Inc. filed this petition under Federal Food, Drug, and Cosmetic Act section 505(j)(2)(C) and 21 C.F.R. § 314.93 requesting that the FDA declare Dexchlorpheniramine Maleate Tablets 1 mg suitable for submission in an Abbreviated New Drug Application, citing the reference liste | Suitability | 2026-06-29 | Open | Senores Pharmaceuticals, Inc. |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4327 · 7 docket documents Pharmobedient Consulting, LLC filed this petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare dexchlorpheniramine maleate powder for solution 2 mg/sachet suitable for submission as an Abbreviated New Drug Application, citing the existing ora | Suitability | 2023-10-03 | Denied | Pharmobedient Consulting, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$2.90
per ml
Lowest NADAC/Unit
$2.90
per ml
Brand NDCs
0
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 15370015004RYCLORA 2 MG/5 ML SOLUTION | $2.90 | ML | — | — | 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.