INDOCIN

FDA-2025-P-1027

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

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

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

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-4323

Zydus Pharmaceuticals (USA), Inc. filed a suitability petition regarding INDOCIN (indomethacin) Suppositories under NDA 017814, requesting FDA evaluation of the approved labeling for this existing drug product.

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-2023-P-3944

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

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-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 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 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-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