Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020976
Company: LIEBEL-FLARSHEIM

• Medication Guide

• Other Important Information from FDA

Products on NDA 20976

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OPTIMARK IN PLASTIC CONTAINER	GADOVERSETAMIDE	9927MG/30ML (330.9MG/ML)	INJECTABLE;INJECTION	Discontinued	None	Yes	No
OPTIMARK IN PLASTIC CONTAINER	GADOVERSETAMIDE	3309MG/10ML (330.9MG/ML)	INJECTABLE;INJECTION	Discontinued	None	Yes	No
OPTIMARK IN PLASTIC CONTAINER	GADOVERSETAMIDE	4963.5MG/15ML (330.9MG/ML)	INJECTABLE;INJECTION	Discontinued	None	Yes	No
OPTIMARK IN PLASTIC CONTAINER	GADOVERSETAMIDE	6618MG/20ML (330.9MG/ML)	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Labels for NDA 020976

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2018	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s028,020975s029,020976s030lbl.pdf
04/26/2018	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020976s029lbl.pdf
08/29/2016	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020937s026,020975s027,020976s028lbl.pdf
11/24/2014	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020937s02420975s2520976s26lbl.pdf
08/07/2014	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020937s023,020975s024,020976s025lbl.pdf
08/26/2013	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020975s2302976s24lbl.pdf
05/21/2013	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020937s021,020975s022,020976s022lbl.pdf
12/20/2010	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020976s016lbl.pdf
09/04/2007	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020937s011,020976s011,020975s012lbl.pdf
08/04/2006	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020937,020975,020976s009lbl.pdf
01/31/2003	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937S003_OptiMark_Prntlbl.pdf
12/08/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark_prntlbl.pdf