Details for New Drug Application (NDA): 018185

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NDA 018185 describes INDOCIN SR, which is a drug marketed by Zyla and is included in one NDA. Additional details are available on the INDOCIN SR profile page.

The generic ingredient in INDOCIN SR is indomethacin. There are fifteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the indomethacin profile page.

Summary for 018185

Tradename:	INDOCIN SR
Applicant:	Zyla
Ingredient:	indomethacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 018185

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CAPSULE, EXTENDED RELEASE;ORAL			Strength	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 23, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 018185

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Zyla	INDOCIN SR	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	018185-001	Feb 23, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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