SULINDAC

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 filed an amendment to a suitability petition for Sulindac Tablets in 75 mg and 100 mg strengths, submitting reference listed drug labeling for Clinoril as requested by the FDA under 21 CFR 314.93(d), noting that the RLD was discontinued for reasons unrelated to safety or eff

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

# 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

FDA-2008-P-0647

Lachman Consultant Services, Inc. filed this petition under Section 505(j)(2)(C) requesting that the FDA declare Sulindac Capsules, 200 mg suitable for submission in an ANDA, with the reference listed drug being Clinoril Sulindac Tablets, 200 mg. The petitioner seeks approval to change the dosage fo