DEXCHLORPHENIRAMINE MALEATE

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

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