Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020180
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROSCAR FINASTERIDE 5MG 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
06/19/1992 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/06/2015 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

03/11/2014 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020180s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020180Orig1s044ltr.pdf
01/16/2013 SUPPL-43 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020180s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020180Orig1s043ltr.pdf
04/11/2012 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020180s040s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020180s040,s041,s042ltr.pdf
04/11/2012 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020180s040s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020180s040,s041,s042ltr.pdf
04/11/2012 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020180s040s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020180s040,s041,s042ltr.pdf
06/09/2011 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020180s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020180s039ltr.pdf
10/04/2010 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020180s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020180s037ltr.pdf
06/10/2011 SUPPL-35 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf
03/23/2010 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020180s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020180s033ltr.pdf
04/23/2004 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20180slr029_proscar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20180slr029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020180_S029_PROSCAR TABLETS.pdf
09/09/2003 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20180slr027_proscar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20180slr027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020180_s027_ProscarTOC.cfm
04/12/2004 SUPPL-26 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020180s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20180se8-026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020180_S026_PROSCAR TABLETS.pdf
06/26/2003 SUPPL-25 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20180slr025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020180_S025_PROSCAR_TABS_AP.pdf
11/26/2002 SUPPL-24 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020180_S024_PROSCAR TABLETS.pdf
10/28/2002 SUPPL-23 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020180_S023_PROSCAR TABLETS.pdf
01/30/2001 SUPPL-22 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020180_s022_PROSCAR 5MG.pdf
09/23/2003 SUPPL-20 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20180slr020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020180_S020_PROSCAR_TABS_AP.pdf
01/17/2001 SUPPL-19 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020180_s019_PROSCAR 5MG.pdf
08/02/1999 SUPPL-18 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020180_s018_PROSCAR 5MG.pdf
12/19/1997 SUPPL-17 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20180-S017_PROSCAR.PDF
03/20/1998 SUPPL-16 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20180-S015&16_PROSCAR.PDF
03/20/1998 SUPPL-15 Efficacy-New Patient Population Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20180-S015&16_PROSCAR.PDF
05/16/1997 SUPPL-14 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/020180_s014_ProscarTOC.cfm
05/12/1997 SUPPL-13 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20180-S013_PROSCAR.PDF
08/28/1996 SUPPL-11 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020180s011_proscar_toc.cfm
07/24/1996 SUPPL-10 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020180_s010_ProscarTOC.cfm
12/30/1994 SUPPL-9 Labeling

Label is not available on this site.

05/18/1994 SUPPL-8 Labeling

Label is not available on this site.

05/18/1994 SUPPL-7 Labeling

Label is not available on this site.

09/16/1993 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/01/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/05/1993 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/22/1992 SUPPL-3 Labeling

Label is not available on this site.

12/22/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/20/1992 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/11/2014 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020180s044lbl.pdf
01/16/2013 SUPPL-43 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020180s043lbl.pdf
04/11/2012 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020180s040s041s042lbl.pdf
04/11/2012 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020180s040s041s042lbl.pdf
04/11/2012 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020180s040s041s042lbl.pdf
06/09/2011 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020180s039lbl.pdf
10/04/2010 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020180s037lbl.pdf
03/23/2010 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020180s033lbl.pdf
04/23/2004 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20180slr029_proscar_lbl.pdf
04/12/2004 SUPPL-26 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020180s026lbl.pdf
09/09/2003 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20180slr027_proscar_lbl.pdf

PROSCAR

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FINASTERIDE FINASTERIDE 5MG TABLET;ORAL Prescription No AB 090121 ACCORD HLTHCARE
FINASTERIDE FINASTERIDE 5MG TABLET;ORAL Prescription No AB 077914 ACTAVIS TOTOWA TEVA
FINASTERIDE FINASTERIDE 5MG TABLET;ORAL Prescription No AB 204304 ALKEM LABS LTD
FINASTERIDE FINASTERIDE 5MG TABLET;ORAL Prescription No AB 078341 AUROBINDO PHARMA
FINASTERIDE FINASTERIDE 5MG TABLET;ORAL Prescription No AB 076437 DR REDDYS LABS LTD
FINASTERIDE FINASTERIDE 5MG TABLET;ORAL Prescription No AB 090061 HETERO LABS LTD III
FINASTERIDE FINASTERIDE 5MG TABLET;ORAL Prescription No AB 090507 SUN PHARM
FINASTERIDE FINASTERIDE 5MG TABLET;ORAL Prescription No AB 076511 TEVA
FINASTERIDE FINASTERIDE 5MG TABLET;ORAL Prescription No AB 078900 ZYDUS PHARMS USA INC
PROSCAR FINASTERIDE 5MG TABLET;ORAL Prescription Yes AB 020180 MERCK

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