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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204118
Company: HOSPIRA

Products on ANDA 204118

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INDOMETHACIN SODIUM	INDOMETHACIN SODIUM	EQ 1MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204118

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/19/2016	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 204118

INDOMETHACIN SODIUM

INJECTABLE;INJECTION; EQ 1MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INDOMETHACIN SODIUM	INDOMETHACIN SODIUM	EQ 1MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	204118	HOSPIRA
INDOMETHACIN SODIUM	INDOMETHACIN SODIUM	EQ 1MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206561	NAVINTA LLC
INDOMETHACIN SODIUM	INDOMETHACIN SODIUM	EQ 1MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	078713	WEST-WARD PHARMS INT

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