DEXCHLORPHENIRAMINE MALEATE | A086835 | SCHERING CORP SUB SCHERING PLOUGH CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2026-P-7181 · 9 docket documents Senores Pharmaceuticals, Inc. filed an amendment to a suitability petition regarding an unspecified drug product or formulation. The document does not provide sufficient detail about the specific drug involved, the original petition's regulatory mechanism, or the particular action requested in this | Suitability | 2026-07-21 | Open | Senores Pharmaceuticals, Inc. |
Citizen Petition from Pharmobedient Consulting, LLC FDA-2025-P-1562 · 5 docket documents Pharmobedient Consulting, LLC filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether Dexchlorpheniramine Maleate Oral Syrup 2 mg/5 mL (application number A088251, held by PAI Holdings LLC), currently listed as discontinu | 505(q) | 2025-06-04 | GrantedDecision letter not yet read | Pharmobedient Consulting, LLC |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2025-P-1531 · 8 docket documents Pharmobedient Consulting, LLC filed a suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Dexchlorpheniramine Maleate Oral Syrup 1 mg/5 mL suitable for submission in an ANDA, with the reference standard being RYCLOR (Dexch | Suitability | 2025-06-03 | Open | Pharmobedient Consulting, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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