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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 091549

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NDA 091549 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, Cosette, Hikma, Novitium Pharma, Hospira, Navinta Llc, and West-ward Pharms Int, and is included in sixty-four NDAs. It is available from thirty-two 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 091549

Tradename:	INDOMETHACIN
Applicant:	Amneal Pharms
Ingredient:	indomethacin
Patents:	0

Pharmacology for NDA: 091549

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 091549

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

Suppliers and Packaging for NDA: 091549

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
INDOMETHACIN	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	091549	ANDA	Amneal Pharmaceuticals LLC	65162-506	65162-506-03	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-03)
INDOMETHACIN	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	091549	ANDA	Amneal Pharmaceuticals LLC	65162-506	65162-506-06	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	75MG
Approval Date:	Dec 1, 2010	TE:	AB	RLD:	No

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