CLISTIN

FDA-2024-P-4934

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

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

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-4321

Newcastle Bioscience LLC filed a citizen petition regarding carbinoxamine maleate, requesting FDA evaluation of the suitability of the approved labeling for this antihistamine drug product. The petition seeks confirmation that the existing approved labeling meets current regulatory standards and req

FDA-2023-P-4283

Pharmobedient Consulting, LLC filed a suitability petition regarding carbinoxamine maleate, requesting FDA guidance on the drug substance's suitability for use in pharmaceutical formulations and generic drug applications.

FDA-2023-P-4283

Pharmobedient Consulting, LLC filed a suitability petition regarding carbinoxamine maleate, requesting FDA evaluation of the drug's suitability for abbreviated new drug application (ANDA) development to support generic drug manufacturing.

FDA-2023-P-4283

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-2023-P-4283

Pharmobedient Consulting LLC filed a citizen petition requesting that the FDA establish suitability findings for carbinoxamine maleate, enabling the use of this active pharmaceutical ingredient in abbreviated new drug applications (ANDAs) for generic drug products.

FDA-2023-P-4322

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-4322

Pharmobedient Consulting, LLC filed a suitability petition regarding carbinoxamine maleate powder, requesting FDA evaluation of the drug substance's suitability for use in pharmaceutical applications under the agency's established regulatory framework for drug substance acceptability determinations.

FDA-1998-P-0664

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