Details for New Drug Application (NDA): 204118

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NDA 204118 describes INDOMETHACIN SODIUM, which is a drug marketed by Hikma, Hospira, and Navinta Llc, and is included in three NDAs. Additional details are available on the INDOMETHACIN SODIUM profile page.

The generic ingredient in INDOMETHACIN SODIUM 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 204118

Tradename:	INDOMETHACIN SODIUM
Applicant:	Hospira
Ingredient:	indomethacin sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1MG BASE/VIAL
Approval Date:	Apr 19, 2016	TE:		RLD:	No

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