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New Drug Application (NDA): 020788
Company: ORGANON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPECIA FINASTERIDE 1MG TABLET;ORAL Prescription AB 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
12/19/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020788_propecia_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/01/2022 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020788s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020788Orig1s030ltr.pdf
06/15/2021 SUPPL-28 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020788s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020788Orig1s028ltr.pdf
01/11/2016 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/31/2014 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020788s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020788Orig1s024ltr.pdf
04/11/2012 SUPPL-23 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020788s020s021s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020788s020,s021,s023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020788Orig1s023.pdf
06/09/2011 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020788Orig1s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020788s022ltr.pdf
04/11/2012 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020788s020s021s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020788s020,s021,s023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020788Orig1s021.pdf
04/11/2012 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020788s020s021s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020788s020,s021,s023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020788Orig1s020.pdf
04/13/2011 SUPPL-18 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020788s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020788s018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020788Orig1s018.pdf
03/11/2011 SUPPL-17 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020788s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020788s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020788Orig1s017.pdf
06/10/2011 SUPPL-16 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf
03/24/2010 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020788s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020788s015ltr.pdf
11/01/2006 SUPPL-14 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

10/21/2004 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20788s002,010,011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20788s002,010,011ltr.pdf
10/21/2004 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20788s002,010,011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20788s002,010,011ltr.pdf
10/30/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/2002 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20788S4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20788s4s5s7ltr.pdf
07/18/2000 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/10/2002 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20788S4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20788s4s5s7ltr.pdf
04/10/2002 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20788S4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20788s4s5s7ltr.pdf
12/08/2001 SUPPL-3 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20788s3lbl.pdf
10/21/2004 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20788s002,010,011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20788s002,010,011ltr.pdf
11/03/1998 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/01/2022 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020788s030lbl.pdf
06/15/2021 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020788s028lbl.pdf
06/15/2021 SUPPL-28 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020788s028lbl.pdf
01/31/2014 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020788s024lbl.pdf
04/11/2012 SUPPL-23 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020788s020s021s023lbl.pdf
04/11/2012 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020788s020s021s023lbl.pdf
04/11/2012 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020788s020s021s023lbl.pdf
04/11/2012 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020788s020s021s023lbl.pdf
06/09/2011 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020788Orig1s022lbl.pdf
04/13/2011 SUPPL-18 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020788s018lbl.pdf
03/11/2011 SUPPL-17 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020788s017lbl.pdf
03/24/2010 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020788s015lbl.pdf
10/21/2004 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20788s002,010,011lbl.pdf
10/21/2004 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20788s002,010,011lbl.pdf
10/21/2004 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20788s002,010,011lbl.pdf
04/10/2002 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20788S4lbl.pdf
04/10/2002 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20788S4lbl.pdf
04/10/2002 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20788S4lbl.pdf
12/08/2001 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20788s3lbl.pdf

PROPECIA

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FINASTERIDE FINASTERIDE 1MG TABLET;ORAL Prescription No AB 091643 ACCORD HLTHCARE
FINASTERIDE FINASTERIDE 1MG TABLET;ORAL Prescription No AB 207750 ALKEM LABS LTD
FINASTERIDE FINASTERIDE 1MG TABLET;ORAL Prescription No AB 203687 AUROBINDO PHARMA LTD
FINASTERIDE FINASTERIDE 1MG TABLET;ORAL Prescription No AB 076436 DR REDDYS LABS INC
FINASTERIDE FINASTERIDE 1MG TABLET;ORAL Prescription No AB 090060 HETERO LABS LTD III
FINASTERIDE FINASTERIDE 1MG TABLET;ORAL Prescription No AB 090508 SUN PHARM
PROPECIA FINASTERIDE 1MG TABLET;ORAL Prescription Yes AB 020788 ORGANON
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