POLMON

FDA-2026-P-7181

Senores Pharmaceuticals, Inc. filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Dexchlorpheniramine Maleate Tablets 1 mg suitable for submission in an ANDA, with the reference listed drug being POLMON oral solution

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 a suitability petition regarding Polmon, requesting that the FDA make a determination on the suitability of the product for abbreviated approval pathways or other regulatory mechanisms related to drug development and commercialization.

FDA-2023-P-4327

Pharmobedient Consulting LLC filed a citizen petition regarding suitability determinations for Polmon, requesting FDA action on regulatory assessments related to the drug's development pathway or approval status.

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