Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019841
Company: MALLINKRODT NUCLEAR
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
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.

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

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