Drugs@FDA: FDA Approved Drug Products

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

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

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