INDOCIN

FDA-2025-P-1164

Rising Pharma Holdings, Inc. filed an amendment to its suitability petition FDA-2025-P-1164, responding to an FDA information request dated May 22, 2025, regarding its petition to file an ANDA for Indomethacin Capsules USP, 18.75 mg and 37.5 mg. Rising submitted the reference listed drug product lab

FDA-2023-P-4323

Zydus Pharmaceuticals (USA), Inc. filed a citizen petition regarding the suitability of INDOCIN (indomethacin) suppositories as a reference listed drug for abbreviated new drug application purposes. The petition seeks FDA determination on whether the RLD meets the regulatory criteria for use as a re

FDA-2021-P-0344

Zydus Pharmaceuticals USA Inc filed a suitability petition regarding the prescribing information for Indocin, which contains indomethacin as the active pharmaceutical ingredient. The petition requests FDA guidance on the suitability of the current prescribing information for the drug product.

FDA-2021-P-0344

Zydus Pharmaceuticals USA Inc filed a suitability petition requesting FDA confirmation that INDOCIN indomethacin suppositories can be used as a reference listed drug for purposes of submitting abbreviated new drug applications for generic indomethacin suppository products.

FDA-2021-P-0344

Zydus Pharmaceuticals USA Inc filed a suitability petition regarding the approved labeling for INDOCIN (indomethacin) suppositories under an NDA, seeking confirmation that the labeling is suitable for use in their proposed generic formulation.

FDA-1985-P-0379

Forest Laboratories, Inc. submitted this petition under section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting permission to file an abbreviated new drug application for a 75 mg indomethacin controlled release tablet, based on the listed drug Indocin SR 75 mg sustained release ca