Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017478
Company: LANTHEUS MEDCL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GALLIUM CITRATE GA 67 GALLIUM CITRATE GA-67 2mCi/ML INJECTABLE;INJECTION Prescription BS No 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
05/17/1976 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
08/06/2018 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017478s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017478Orig1s016ltr.pdf
03/09/2015 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/21/2011 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017478s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017478s014ltr.pdf
03/03/2004 SUPPL-13 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17478scs013ltr.pdf
01/02/1987 SUPPL-11 Labeling

Label is not available on this site.

08/15/1983 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

07/12/1982 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1984 SUPPL-7 Labeling

Label is not available on this site.

07/20/1978 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/21/1979 SUPPL-4 Efficacy

Label is not available on this site.

01/16/1979 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/06/2018 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017478s016lbl.pdf
10/21/2011 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017478s014lbl.pdf

GALLIUM CITRATE GA 67

There are no Therapeutic Equivalents.

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