Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019841
Company: CURIUM

Products on NDA 019841

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INDIUM IN 111 CHLORIDE	INDIUM IN-111 CHLORIDE	5mCi/0.5ML	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019841

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/1994	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/26/2017	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
02/19/2002	SUPPL-3	Labeling	Label (PDF) Letter		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/in111mal021902LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/in111mal021902L.htm
07/03/1996	SUPPL-2	Labeling		Label is not available on this site.
10/28/1996	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 019841

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/19/2002	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/in111mal021902LB.pdf