SULINDAC | N017911 | MERCK RESEARCH LABORATORIES DIV MERCK CO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc FDA-2025-P-0753 · 6 docket documents 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 | Suitability | 2025-03-17 | Open | Senores Pharmaceuticals, Inc |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4358 · 9 docket documents 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 | Suitability | 2023-10-06 | Granted | Pharmobedient Consulting, LLC |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2008-P-0647 · 6 docket documents 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 The petitioner seeks approval to change the dosage fo | Other | 2008-12-17 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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