CLISTIN

FDA-2024-P-4934 · 7 docket documents

Hyman, Phelps & McNamara, P.C., on behalf of a client, filed a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Carbinoxamine Maleate Tablets, 3 mg, suitable for submission as an Abbreviated New Drug Application, with t

FDA-2024-P-1788 · 8 docket documents

Pharmobedient Consulting, LLC filed this suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Carbinoxamine Maleate Tablets, 2 mg suitable for submission in an Abbreviated New Drug Application, with t

FDA-2023-P-4321 · 12 docket documents

Newcastle Bioscience LLC filed a suitability petition regarding carbinoxamine maleate, an antihistamine drug product listed in the FDA's Orange Book of approved drug products with therapeutic equivalence evaluations. The petition addresses questions concerning the suitability of carbinoxamine maleat

FDA-2023-P-4322 · 7 docket documents

Pharmobedient Consulting, LLC filed a suitability petition regarding carbinoxamine maleate solution, requesting FDA evaluation of the drug's suitability for inclusion in the ANDA process or establishing appropriate regulatory pathways for generic development.

FDA-2023-P-4283 · 8 docket documents

Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.93 requesting that the FDA declare Carbinoxamine Maleate Orally Disintegrating Tablets 4 mg suitable for submission in an ANDA, with the proposed dosage

FDA-1998-P-0664 · 9 docket documents

Sage Pharmaceuticals filed this citizen petition under 21 CFR 314.122(a) and 505(j)(2)(c) requesting that the FDA determine McNeil Laboratories' voluntary withdrawal of its NDA for Clistin® (carbinoxamine maleate 4 mg tablets) was not for safety or effectiveness reasons, thereby allowing Sage to fil