DOLOBID

FDA-2023-P-4280

Pharmobedient Consulting LLC filed a citizen petition requesting that the FDA determine whether Dolobid is a suitable reference listed drug for purposes of approving abbreviated new drug applications (ANDAs). The petition addresses the qualifications and appropriateness of Dolobid as a reference sta

FDA-2023-P-4280

Pharmobedient Consulting, LLC submitted a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to file an ANDA for Diflunisal Orally Disintegrating Tablets in 250 mg and 500 mg strengths, which differ in dosage form from the reference st

FDA-2023-P-4280

Pharmobedient Consulting, LLC filed a petition requesting FDA guidance on the suitability of diflunisal as a reference standard for regulatory purposes. The petition seeks clarification on whether diflunisal meets the criteria for use as a reference material in pharmaceutical testing and quality con

FDA-2023-P-4280

Pharmobedient Consulting, LLC filed a citizen petition regarding diflunisal tablets, film coated, requesting that the FDA determine the suitability of this drug product for regulatory purposes. The petition addresses the regulatory classification and eligibility of diflunisal tablets under the appli

FDA-2023-P-4280

Pharmobedient Consulting, LLC filed a suitability petition requesting FDA determination that diflunisal orally disintegrating tablets are suitable for abbreviated new drug application (ANDA) review, allowing generic manufacturers to develop bioequivalent formulations of this nonsteroidal anti-inflam