INDOCIN

FDA-2025-P-1164

Rising Pharma Holdings, Inc. submitted this suitability petition under section 502(j)(2)(C) of the FDC Act requesting a declaration that an Abbreviated New Drug Application may be submitted for Indomethacin Capsules USP in 18.75 mg and 37.5 mg strengths, which differ from the reference listed drug I

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 oral indomethacin, requesting FDA evaluation of the drug's suitability for approval under the abbreviated new drug application pathway.

FDA-2021-P-0344

Zydus Pharmaceuticals USA Inc. filed a petition regarding the regulatory suitability of indomethacin as a reference drug, requesting FDA evaluation through the FAERS adverse event reporting system to support potential generic drug applications.

FDA-2021-P-0344

Zydus Pharmaceuticals USA Inc filed a suitability petition regarding indomethacin suppository, and ProPharma Group submitted comments on that petition. This document represents a response to ProPharma Group's comments on Zydus's suitability petition for the indomethacin suppository product.

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 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-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-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