Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020180
Company: ORGANON
Company: ORGANON
| 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 |
|---|---|---|---|---|---|
| 08/25/2021 | SUPPL-49 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020180s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020180Orig1s049ltr.pdf | |
| 04/13/2021 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020180s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020180Orig1s048ltr.pdf | |
| 06/15/2021 | SUPPL-47 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020180s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020180Orig1s047ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 08/25/2021 | SUPPL-49 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020180s049lbl.pdf | |
| 06/15/2021 | SUPPL-47 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020180s047lbl.pdf | |
| 06/15/2021 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020180s047lbl.pdf | |
| 04/13/2021 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020180s048lbl.pdf | |
| 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 | 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 | ORGANON |