Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202008
Company: AVID RADIOPHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMYVID FLORBETAPIR F-18 10ML (13.5-51mCi/ML) SOLUTION;INTRAVENOUS Discontinued None No No
AMYVID FLORBETAPIR F-18 10-30ML (13.5-51mCi/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
AMYVID FLORBETAPIR F-18 10-50ML (13.5-51mCi/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
04/06/2012 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202008s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202008Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202008_Florbetapir_Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/22/2016 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/09/2016 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/09/2015 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/25/2015 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/09/2015 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/14/2014 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/12/2013 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202008s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202008Orig1s020ltr.pdf
11/08/2013 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/25/2013 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/22/2013 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/06/2013 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/27/2013 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/22/2013 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/06/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/06/2013 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/19/2013 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/19/2013 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/13/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/18/2013 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/19/2013 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/18/2013 SUPPL-6 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
12/12/2013 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202008s020lbl.pdf
04/06/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202008s000lbl.pdf

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