Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021344
Company: ASTRAZENECA
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 | 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 |