INDOCIN SR

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 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 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 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 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