Documents
Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL | 1MG | 1 | PROPECIA | FINASTERIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1997-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2004-10-21 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2001-12-08 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2002-04-10 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2002-04-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2000-07-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2002-04-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2002-10-30 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2004-10-21 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2004-10-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2006-11-01 | N/A |
| LABELING; Labeling | SUPPL | 15 | AP | 2010-03-24 | UNKNOWN |
| LABELING; Labeling | SUPPL | 16 | AP | 2011-06-10 | UNKNOWN |
| LABELING; Labeling | SUPPL | 17 | AP | 2011-03-11 | UNKNOWN |
| LABELING; Labeling | SUPPL | 18 | AP | 2011-04-13 | UNKNOWN |
| LABELING; Labeling | SUPPL | 20 | AP | 2012-04-11 | UNKNOWN |
| LABELING; Labeling | SUPPL | 21 | AP | 2012-04-11 | UNKNOWN |
| LABELING; Labeling | SUPPL | 22 | AP | 2011-06-09 | UNKNOWN |
| LABELING; Labeling | SUPPL | 23 | AP | 2012-04-11 | UNKNOWN |
| LABELING; Labeling | SUPPL | 24 | AP | 2014-01-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2016-01-11 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2021-06-15 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2022-08-01 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 20 | Null | 7 |
| SUPPL | 21 | Null | 15 |
| SUPPL | 22 | Null | 6 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 28 | Null | 7 |
| SUPPL | 30 | Null | 7 |
TE Codes
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 20788
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)