DEXCHLORPHENIRAMINE MALEATE

FDA-2026-P-7181 · 7 docket documents

Senores Pharmaceuticals, Inc. filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act to request FDA approval to submit an ANDA for Dexchlorpheniramine Maleate Tablets 1 mg, which would differ in dosage form and strength from the reference listed drug P

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