Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206561
Company: NAVINTA LLC

Products on ANDA 206561

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206561

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/19/2017	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206561Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206561Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/07/2023	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 206561

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/19/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206561Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 206561

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