Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020788
Company: ORGANON
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-Patient Package Insert, Labeling-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-Package Insert, Labeling-Container/Carton Labels |
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-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020788s028lbl.pdf | |
| 06/15/2021 | SUPPL-28 | Labeling-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 |