Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204677
Company: LIFE MOLECULAR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEURACEQ FLORBETABEN F-18 30ML (1.4-135mCi/ML) SOLUTION;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
03/19/2014 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204677s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204677Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204677Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204677Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/10/2018 SUPPL-15 Labeling-Container/Carton Labels

Label is not available on this site.

06/16/2017 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204677s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204677Orig1s014ltr.pdf
03/08/2016 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/25/2016 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204677s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204677Orig1s012ltr.pdf
10/03/2016 SUPPL-11 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204677s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204677Orig1s011ltr.pdf
01/25/2016 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/18/2015 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/19/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/04/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/13/2014 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/15/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/15/2014 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/04/2014 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204677s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204677Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/16/2017 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204677s014lbl.pdf
10/03/2016 SUPPL-11 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204677s011lbl.pdf
08/25/2016 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204677s012lbl.pdf
04/04/2014 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204677s001lbl.pdf
03/19/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204677s000lbl.pdf

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