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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 216184

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NDA 216184 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 216184

Tradename:	INDOMETHACIN
Applicant:	Zydus Lifesciences
Ingredient:	indomethacin
Patents:	0

Pharmacology for NDA: 216184

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 216184

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

Suppliers and Packaging for NDA: 216184

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
INDOMETHACIN	indomethacin	SUPPOSITORY;RECTAL	216184	ANDA	Zydus Pharmaceuticals USA Inc.	70710-1852	70710-1852-7	5 BLISTER PACK in 1 CARTON (70710-1852-7) / 6 SUPPOSITORY in 1 BLISTER PACK (70710-1852-6)
INDOMETHACIN	indomethacin	SUPPOSITORY;RECTAL	216184	ANDA	Zydus Pharmaceuticals USA Inc.	70710-1958	70710-1958-7	5 BLISTER PACK in 1 CARTON (70710-1958-7) / 6 SUPPOSITORY in 1 BLISTER PACK (70710-1958-6)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUPPOSITORY;RECTAL			Strength	50MG
Approval Date:	Aug 2, 2023	TE:	AB	RLD:	No
Regulatory Exclusivity Expiration:	Jan 30, 2024
Regulatory Exclusivity Use:	COMPETITIVE GENERIC THERAPY

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