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 requesting FDA guidance on the regulatory pathway for developing a pharmaceutical product. The amendment seeks clarification on whether the proposed product qualifies for approval under the ANDA pathway for a generic drug app | 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 | Granted | 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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