CLINORIL

FDA-2025-P-0753

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 Sulindac Capsules in 150 mg and 200 mg strengths suitable for submission as an ANDA, changing the dosage form from tablets to capsules b

FDA-2023-P-4358

Pharmobedient Consulting filed an amendment to a suitability petition regarding CLINORIL (sulindac) labeling. The petition requests FDA action to amend the product labeling for this nonsteroidal anti-inflammatory drug.

FDA-2023-P-4358

Pharmobedient Consulting, LLC filed a suitability petition regarding Clinoril (sulindac) seeking to establish the suitability of the drug for inclusion in the Orange Book, which would allow for abbreviated new drug applications (ANDAs) to reference the approved brand-name product.

FDA-2023-P-4358

Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Sulindac Tablets in 75 mg and 100 mg strengths suitable for submission in an ANDA, with the reference listed drug being Merck's CLINORI

FDA-2023-P-4358

# Summary Pharmobedient Consulting, LLC filed a citizen petition regarding sulindac tablets, requesting FDA review of proposed revisions to the product's prescribing information as of October 3, 2023. The petition seeks FDA suitability determination for the sulindac tablet formulation, likely under