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INDOCIN

NDA

INDOMETHACIN SODIUM | N018878 | RECORDATI RARE DISEASES INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic Dissection NCT06968806	Phase 3	Recruiting	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	360	2025-10-27 → 2028-09-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain4 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

SOLARA ACTIVE PHARMA SCIENCES LTDINDOMETHACIN SODIUM

DMF 227512009

GLAND PHARMA LTDINDOMETHACIN SODIUM USP

DMF 254012011

GLAND PHARMA LTDINDOMETHACIN SODIUM USP

DMF 272822013

FIS FABBRICA ITALIANA SINTETICI SPAINDOMETHACIN SODIUM

DMF 294412015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jan 30, 1985

No patent or exclusivity listings for this strength.