DEXCHLORPHENIRAMINE MALEATE

FDA-2026-P-7181 · 7 docket documents

Senores Pharmaceuticals, Inc. filed this petition under Federal Food, Drug, and Cosmetic Act section 505(j)(2)(C) and 21 C.F.R. § 314.93 requesting that the FDA declare Dexchlorpheniramine Maleate Tablets 1 mg suitable for submission in an Abbreviated New Drug Application, citing the reference liste

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

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

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