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. 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-2025-P-1027 · 7 docket documents

The law firm Hyman, Phelps & McNamara, P.C., on behalf of a client, filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Indomethacin Suppositories, 100 mg, suitable for submission as an ANDA, wit

FDA-2023-P-5368 · 7 docket documents

Hopewell Pharma Ventures, Inc. filed this suitability petition pursuant to 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.93 requesting that the FDA determine Indomethacin Suppositories, 100 mg, is suitable for submission in an ANDA, with the reference listed drug being Egal

FDA-2023-P-4360 · 3 docket documents

Zydus Pharmaceuticals (USA) Inc. filed this citizen petition under 21 C.F.R. § 10.25 et seq. requesting that the FDA investigate and take prompt enforcement action against Wells Pharma's unapproved Indomethacin suppository 100 mg product, which is not included in the FDA's 503(B) outsourcing facilit

FDA-2023-P-4323 · 8 docket documents

Zydus Pharmaceuticals (USA) Inc. filed this suitability petition under Section 505(j)(2)(C) and 21 C.F.R. § 314.93 requesting that the FDA determine that Indomethacin Suppositories, 100 mg, is suitable for submission in an ANDA, with the reference listed drug being INDOCIN® (indomethacin) Suppositor

FDA-2023-P-3944 · 7 docket documents

Zydus Pharmaceuticals (USA) Inc., on behalf of Zydus Lifesciences Ltd., filed this citizen petition on September 14, 2023, requesting that the FDA ensure the currently marketed Indocin Suppositories USP 50 mg approved under ANDA 073314 complies with ICH guidelines and established impurity acceptance

FDA-2023-P-0806 · 3 docket documents

Hopewell Pharma Ventures, Inc. filed this suitability petition under 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine Indomethacin Suppositories, 100 mg, is suitable for submission in an ANDA, with INDOCIN Suppositories, 50 mg (NDA 017814) as the reference l

FDA-2022-P-1667 · 3 docket documents

Chem IQ FZCO filed this citizen petition requesting that the FDA ensure the currently marketed Indomethacin Suppositories 50 mg approved under ANDA 073314 complies with ICH guidelines and established impurity acceptance criteria, and refrain from approving future ANDAs that justify higher impurity l

FDA-2021-P-0344 · 14 docket documents

Zydus Pharmaceuticals USA Inc. filed a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA determine Indomethacin Suppositories, 100 mg, is suitable for submission in an ANDA, with the Reference Listed Drug b

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