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Last Updated: April 18, 2025

Details for New Drug Application (NDA): 201807

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NDA 201807 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, Cosette, Hikma, Novitium Pharma, Hospira, and Navinta Llc, and is included in sixty-six 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 201807

Tradename:	INDOMETHACIN
Applicant:	Hetero Labs Ltd Iii
Ingredient:	indomethacin
Patents:	0

Pharmacology for NDA: 201807

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 201807

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

Suppliers and Packaging for NDA: 201807

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
INDOMETHACIN	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	201807	ANDA	Camber Pharmaceuticals, Inc.	31722-565	31722-565-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-01)
INDOMETHACIN	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	201807	ANDA	Camber Pharmaceuticals, Inc.	31722-565	31722-565-05	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	75MG
Approval Date:	Sep 28, 2012	TE:	AB	RLD:	No

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