DEXCHLORPHENIRAMINE MALEATE | A202520 | PHARMOBEDIENT CONSULTING LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2026-P-7181 · 9 docket documents Senores Pharmaceuticals, Inc. filed a petition requesting FDA guidance on the suitability of processes and proposed manufacturing methods for generic drug development, seeking regulatory clarification on whether their proposed approaches would be acceptable for submission in an Abbreviated New Drug | 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 | DeniedDecision letter not yet read | 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.