CLISTIN

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-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-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-4322

Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the FDC Act requesting FDA approval to submit an ANDA for Carbinoxamine Maleate Powder for Solution in 2 mg and 4 mg sachets, which differs in dosage form from the reference listed drug CLISTIN oral solution

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-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 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 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.