Details for New Drug Application (NDA): 206561

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NDA 206561 describes INDOMETHACIN SODIUM, which is a drug marketed by Hospira, Navinta Llc, and West-ward Pharms Int, 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 206561

Tradename:	INDOMETHACIN SODIUM
Applicant:	Navinta Llc
Ingredient:	indomethacin sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1MG BASE/VIAL
Approval Date:	Jul 19, 2017	TE:	AP	RLD:	No

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