Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018489
Company: DRAXIMAGE

Products on NDA 018489

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TECHNESCAN HIDA	TECHNETIUM TC-99M LIDOFENIN KIT	N/A	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018489

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/1986	ORIG-1	Approval	Type 1 - New Molecular Entity	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
05/29/2013	SUPPL-52	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018469s052lbl.pdf
12/07/2007	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 018489

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/29/2013	SUPPL-52	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018469s052lbl.pdf