Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208547
Company: AAA USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NETSPOT GALLIUM DOTATATE GA-68 2.1-5.5mCi/ML POWDER;INTRAVENOUS 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
06/01/2016 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208547s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208547Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208547Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208547Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2018 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

09/27/2018 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/12/2018 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208547s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208547Orig1s011ltr.pdf
01/20/2017 SUPPL-4 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208547s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208547Orig1s004ltr.pdf
10/31/2016 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/02/2016 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208547s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208547Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/12/2018 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208547s011lbl.pdf
01/20/2017 SUPPL-4 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208547s004lbl.pdf
09/02/2016 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208547s002lbl.pdf
06/01/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208547s000lbl.pdf

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