INDOCIN

FDA-2025-P-7377 · 16 docket documents

Wiley Rein LLP filed this citizen petition on behalf of an unnamed client requesting that the FDA revoke approval of or mandate reformulation of all NDAs and ANDAs for indomethacin rectal suppositories containing the excipients butylated hydroxytoluene (BHT) and butylated hydroxyanisole (BHA), citin

FDA-2025-P-1164 · 5 docket documents

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 · 8 docket documents

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 · 14 docket documents

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