Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017707
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MPI INDIUM DTPA IN 111 INDIUM IN-111 PENTETATE DISODIUM 1mCi/ML INJECTABLE;INTRATHECAL 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
02/18/1982 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
12/22/2016 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/21/2004 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17707s010ltr.pdf
04/30/2002 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/30/1996 SUPPL-7 Labeling

Label is not available on this site.

02/28/1995 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/22/1985 SUPPL-3 Labeling

Label is not available on this site.

09/27/1984 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

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