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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 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription AO Yes Yes
FASLODEX FULVESTRANT 125MG/2.5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Discontinued None Yes 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
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
01/19/2021 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021344s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021344Orig1s044ltr.pdf
07/28/2020 SUPPL-42 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021344s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021344Orig1s042ltr.pdf
05/13/2020 SUPPL-41 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021344s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021344Orig1s041ltr.pdf
05/20/2019 SUPPL-39 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021344Orig1s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021344Orig1s039ltr.pdf
11/21/2019 SUPPL-38 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021344s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021344Orig1s038ltr.pdf
03/11/2019 SUPPL-37 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021344s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021344Orig1s037ltr.pdf
07/05/2018 SUPPL-36 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021344s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021344Orig1s036Ltr.pdf
11/14/2017 SUPPL-35 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021344s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021344Orig1s035ltr.pdf
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 Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021344Orig1s033.pdf 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)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021344s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021344Orig1s026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021344Orig1s026.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)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021344s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021344Orig1s019,s020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021344Orig1s020.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)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021344s007s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021344s007,s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021344Orig1s012.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
01/19/2021 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021344s044lbl.pdf
07/28/2020 SUPPL-42 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021344s042lbl.pdf
05/13/2020 SUPPL-41 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021344s041lbl.pdf
11/21/2019 SUPPL-38 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021344s038lbl.pdf
05/20/2019 SUPPL-39 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021344Orig1s039lbl.pdf
05/20/2019 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021344Orig1s039lbl.pdf
03/11/2019 SUPPL-37 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021344s037lbl.pdf
07/05/2018 SUPPL-36 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021344s036lbl.pdf
11/14/2017 SUPPL-35 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021344s035lbl.pdf
08/25/2017 SUPPL-34 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021344s034lbl.pdf
01/24/2017 SUPPL-33 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021344Orig1s033.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

FASLODEX

SOLUTION;INTRAMUSCULAR; 250MG/5ML (50MG/ML)
TE Code = AO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FASLODEX FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription Yes AO 021344 ASTRAZENECA
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 211689 ACCORD HLTHCARE
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 215077 ALEMBIC
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 210044 AMNEAL
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 211422 CHIA TAI TIANQING
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 209246 DR REDDYS
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 208811 EUGIA PHARMA
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 215169 EUGIA PHARMA
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 210326 FRESENIUS KABI USA
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 207754 GLENMARK PHARMS INC
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 209714 HBT LABS INC
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 214682 JIANGSU HANSOH PHARM
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 205871 SAGENT PHARMS INC
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 205935 SANDOZ
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 213553 XIROMED
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 215234 ZYDUS PHARMS
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