Details for New Drug Application (NDA): 017814

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NDA 017814 describes INDOCIN, which is a drug marketed by Zyla Life Sciences, Recordati Rare, and Zyla, and is included in five NDAs. It is available from one supplier. Additional details are available on the INDOCIN profile page.

The generic ingredient in INDOCIN 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 017814

Tradename:	INDOCIN
Applicant:	Zyla Life Sciences
Ingredient:	indomethacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 017814

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUPPOSITORY;RECTAL			Strength	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 13, 1984	TE:		RLD:	Yes

Expired US Patents for NDA 017814

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Zyla Life Sciences	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984	⤷ Subscribe	⤷ Subscribe
Zyla Life Sciences	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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