Documents
Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL | 5MG | 1 | PROSCAR | FINASTERIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1992-06-19 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1992-12-22 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 1992-12-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1993-04-05 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1993-09-01 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1993-09-16 | PRIORITY |
| LABELING; Labeling | SUPPL | 7 | AP | 1994-05-18 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1994-05-18 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1994-12-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1996-07-24 | PRIORITY |
| LABELING; Labeling | SUPPL | 11 | AP | 1996-08-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1997-05-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1997-05-16 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 1998-03-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 1998-03-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 17 | AP | 1997-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 1999-08-02 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2001-01-17 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2003-09-23 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2001-01-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2002-10-28 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2002-11-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 25 | AP | 2003-06-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 26 | AP | 2004-04-12 | UNKNOWN |
| LABELING; Labeling | SUPPL | 27 | AP | 2003-09-09 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2004-04-23 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2010-03-23 | UNKNOWN |
| LABELING; Labeling | SUPPL | 35 | AP | 2011-06-10 | UNKNOWN |
| LABELING; Labeling | SUPPL | 37 | AP | 2010-10-04 | UNKNOWN |
| LABELING; Labeling | SUPPL | 39 | AP | 2011-06-09 | UNKNOWN |
| LABELING; Labeling | SUPPL | 40 | AP | 2012-04-11 | UNKNOWN |
| LABELING; Labeling | SUPPL | 41 | AP | 2012-04-11 | UNKNOWN |
| LABELING; Labeling | SUPPL | 42 | AP | 2012-04-11 | UNKNOWN |
| LABELING; Labeling | SUPPL | 43 | AP | 2013-01-16 | UNKNOWN |
| LABELING; Labeling | SUPPL | 44 | AP | 2014-03-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 2015-07-06 | PRIORITY |
| LABELING; Labeling | SUPPL | 47 | AP | 2021-06-15 | STANDARD |
| LABELING; Labeling | SUPPL | 48 | AP | 2021-04-13 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2021-08-25 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 33 | Null | 7 |
| SUPPL | 35 | Null | 4 |
| SUPPL | 37 | Null | 6 |
| SUPPL | 39 | Null | 7 |
| SUPPL | 40 | Null | 15 |
| SUPPL | 41 | Null | 6 |
| SUPPL | 42 | Null | 6 |
| SUPPL | 43 | Null | 6 |
| SUPPL | 44 | Null | 7 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 47 | Null | 7 |
| SUPPL | 48 | Null | 7 |
| SUPPL | 49 | Null | 6 |
TE Codes
CDER Filings
cder:Array
(
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[companyName] =>
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[labels] =>
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[supplements] =>
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)
)