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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019292
Company: LIEBEL-FLARSHEIM

Products on NDA 019292

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MD-76R	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	66%;10%	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019292

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/1989	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2017	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019292s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019292ig1s011ltr.pdf
07/06/2015	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019292s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019292Orig1s010ltr.pdf
05/10/2013	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
01/13/1995	SUPPL-8	Labeling		Label is not available on this site.
07/25/1996	SUPPL-7	Manufacturing (CMC)-Formulation		Label is not available on this site.
08/28/1992	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/04/1992	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
08/11/1992	SUPPL-4	Labeling		Label is not available on this site.
03/30/1990	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
04/09/1990	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/04/1990	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 019292

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2017	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019292s011lbl.pdf
07/06/2015	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019292s010lbl.pdf

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