DEXCHLORPHENIRAMINE MALEATE

FDA-2026-P-7181

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

FDA-2026-P-7181

Senores Pharmaceuticals, Inc. filed a suitability petition requesting FDA evaluation of the suitability of 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine as an active pharmaceutical ingredient for use in developing an NDA or ANDA application.

FDA-2025-P-1562

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

FDA-2025-P-1531

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

FDA-2023-P-4327

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