Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021344
Company: ASTRAZENECA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FASLODEX FULVESTRANT 50MG/ML INJECTABLE;INTRAMUSCULAR 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
04/25/2002 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21344lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21344.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-344_FulvestrantFaslodex.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/25/2017 SUPPL-34 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021344s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021344Orig1s034ltr.pdf
01/24/2017 SUPPL-33 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021344Orig1s033ltr.pdf
10/26/2016 SUPPL-31 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021344Orig1s031ltr.pdf
06/30/2014 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

07/12/2016 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021344s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021344Orig1s029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021344Orig1s029.pdf
10/31/2016 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

05/19/2016 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021344s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021344Orig1s027ltr.pdf
03/02/2016 SUPPL-26 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021344s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021344Orig1s026ltr.pdf
03/01/2016 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021344s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021344Orig1s025ltr.pdf
08/25/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/08/2013 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/08/2013 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/09/2012 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021344s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021344Orig1s019,s020ltr.pdf
11/09/2012 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021344s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021344Orig1s019,s020ltr.pdf
07/13/2012 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021344s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021344Orig1s018ltr.pdf
09/26/2011 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021344s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021344s014,s015ltr.pdf
09/26/2011 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021344s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021344s014,s015ltr.pdf
05/17/2011 SUPPL-13 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021344s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021344s013ltr.pdf
09/09/2010 SUPPL-12 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021344s007s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021344s007,s012ltr.pdf
09/09/2010 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021344s007s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021344s007,s012ltr.pdf
08/02/2005 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021344s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021344s004ltr.pdf
12/24/2003 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21344se8-001_faslodex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21344se8-001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/25/2017 SUPPL-34 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021344s034lbl.pdf
07/12/2016 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021344s029lbl.pdf
05/19/2016 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021344s027lbl.pdf
03/02/2016 SUPPL-26 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021344s026lbl.pdf
03/01/2016 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021344s025lbl.pdf
11/09/2012 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021344s019s020lbl.pdf
11/09/2012 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021344s019s020lbl.pdf
07/13/2012 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021344s018lbl.pdf
09/26/2011 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021344s015lbl.pdf
09/26/2011 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021344s014lbl.pdf
05/17/2011 SUPPL-13 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021344s013lbl.pdf
09/09/2010 SUPPL-12 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021344s007s012lbl.pdf
09/09/2010 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021344s007s012lbl.pdf
08/02/2005 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021344s004lbl.pdf
12/24/2003 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21344se8-001_faslodex_lbl.pdf
04/25/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21344lbl.pdf

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