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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 091401

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NDA 091401 describes INDOMETHACIN, which is a drug marketed by Able, Amneal Pharms, Aurobindo Pharma, Avanthi Inc, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Inwood Labs, Jubilant Generics, Mylan, Novast Labs, Sandoz, Watson Labs Inc, Zydus Pharms, Ani Pharms, Chartwell Molecules, Cycle, Duramed Pharms Barr, Halsey, Heritage, Heritage Pharma, Ivax Sub Teva Pharms, Mutual Pharm, Parke Davis, Pioneer Pharms, Rising, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Teva, Watson Labs, Zydus Lifesciences, Fresenius Kabi Usa, Amneal, Annora Pharma, Cosette, Hikma, Novitium Pharma, Hospira, and Navinta Llc, and is included in sixty-seven NDAs. It is available from thirty-one suppliers. Additional details are available on the INDOMETHACIN profile page.

The generic ingredient in INDOMETHACIN is indomethacin sodium. There are fifteen drug master file entries for this compound. Additional details are available on the indomethacin sodium profile page.

Summary for 091401

Tradename:	INDOMETHACIN
Applicant:	Sun Pharm Inds Inc
Ingredient:	indomethacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 091401

Anti-Inflammatory Agents, Non-Steroidal
Cardiovascular Agents
Cyclooxygenase Inhibitors
Gout Suppressants
Tocolytic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Mar 28, 2013	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Mar 28, 2013	TE:		RLD:	No

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