Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019862
Company: GE HEALTHCARE

Products on NDA 019862

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INDICLOR	INDIUM IN-111 CHLORIDE	2mCi/0.2ML	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019862

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/1992	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
06/20/2014	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
07/09/2003	SUPPL-14	Labeling		Label is not available on this site.
04/24/2003	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/in111med042403LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/in111med042403L.pdf
02/19/2002	SUPPL-6	Labeling	Label (PDF) Letter		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/in111med021902LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/in111med021902L.htm
10/28/1996	SUPPL-3	Efficacy-New Indication		Label is not available on this site.

Labels for NDA 019862

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/24/2003	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/in111med042403LB.pdf
02/19/2002	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/in111med021902LB.pdf