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INDOCIN

NDA

INDOMETHACIN | N018332 | ZYLA LIFE SCIENCES US 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

4 petitions (4 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 1 - Orange Book Pages of RLD INDOCIN® (indomethacin) Suppositories... 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	Suitability	2023-10-03	Open	Zydus Pharmaceuticals (USA)
Attachment 2 - Indocin prescribing information RE Suitability Petition from Z... 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.	Suitability	2022-08-12	Open	Zydus Pharmaceuticals USA Inc
Attachment 1 Orange Book Pages of RLD INDOCIN indomethacin Suppositories re S... 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.	Suitability	2021-04-01	Open	Zydus Pharmaceuticals USA Inc
Attachment 2 Approved labeling for INDOCIN indomethacin Suppositories NDA re ... 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.	Suitability	2021-04-01	Open	Zydus Pharmaceuticals USA Inc

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain6 active DMFs6 inactive

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

FIS FABBRICA ITALIANA SINTETICI SPAINDOMETHACIN

DMF 31361978

MACLEODS PHARMACEUTICALS LTDINDOMETHACIN

DMF 217402008

CSPC OUYI PHARMACEUTICAL CO LTDINDOMETHACIN

DMF 219842008

HETERO DRUGS LTDINDOMETHACIN

DMF 363642021

AURORE LIFE SCIENCES PRIVATE LTDINDOMETHACIN USP

DMF 367612022

AGNO PHARMAINDOMETHACIN USP

DMF 376382024

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPAInactiveINDOMETHACIN

DMF 26331976

ESTEVE QUIMICA SAInactiveINDOMETHACIN FOR HUMAN USE

DMF 42201981

SIGMA F AND D DIV LTDInactiveINDOMETHACIN

DMF 52581983

EURAND AMERICA INCInactiveINDOMETHACIN

DMF 59781985

SHANGHAI NO 17 PHARMACEUTICAL FACTORYInactiveINDOMETHACIN

DMF 74941988

GUANGDONG PHARMACEUTICAL FACTORYInactiveINDOMETHACIN

DMF 85811990

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Nov 25, 2024	SUPPL -43	View Letter (PDF)
Apr 29, 2021	SUPPL -42	View Letter (PDF)
Mar 28, 2019	SUPPL -40	View Letter (PDF)
May 12, 2016	SUPPL -37	View Letter (PDF)
May 12, 2016	SUPPL -38	View Letter (PDF)
Feb 2, 2007	SUPPL -30	View Letter (PDF)
Mar 29, 2005	SUPPL -28	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 25MG/5ML

RLDAB

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Oct 10, 1985

No patent or exclusivity listings for this strength.