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 suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act to request FDA approval to submit an ANDA for Dexchlorpheniramine Maleate Tablets 1 mg, which would differ in dosage form and strength from the reference listed drug P | 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.