Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL | 25MG | 0 | SPIRONOLACTONE | SPIRONOLACTONE |
FDA Submissions
| ORIG | 1 | AP | 1980-07-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1982-05-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1982-04-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1983-01-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1983-01-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1983-08-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1983-08-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1984-07-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1986-08-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1986-08-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1986-08-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1986-08-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1987-01-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1987-01-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1987-01-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1988-04-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1988-04-20 | |
| LABELING; Labeling | SUPPL | 39 | AP | 1991-04-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1994-06-20 | |
| LABELING; Labeling | SUPPL | 41 | AP | 1995-01-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1995-12-01 | |
| LABELING; Labeling | SUPPL | 43 | AP | 1996-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1997-10-21 | |
| LABELING; Labeling | SUPPL | 45 | AP | 1998-06-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1999-05-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 2000-02-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 2001-01-11 | |
| LABELING; Labeling | SUPPL | 49 | AP | 2000-09-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 2001-05-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 2002-09-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 2002-12-16 | |
| LABELING; Labeling | SUPPL | 62 | AP | 2009-02-25 | |
| LABELING; Labeling | SUPPL | 65 | AP | 2014-09-22 | STANDARD |
| LABELING; Labeling | SUPPL | 66 | AP | 2014-09-22 | STANDARD |
| LABELING; Labeling | SUPPL | 67 | AP | 2014-09-22 | STANDARD |
| LABELING; Labeling | SUPPL | 69 | AP | 2015-05-19 | STANDARD |
Submissions Property Types
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 48 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 51 | Null | 0 |
| SUPPL | 52 | Null | 0 |
| SUPPL | 65 | Null | 7 |
| SUPPL | 66 | Null | 7 |
| SUPPL | 67 | Null | 7 |
| SUPPL | 69 | Null | 7 |
CDER Filings
CHARTWELL RX
cder:Array
(
[0] => Array
(
[ApplNo] => 86809
[companyName] => CHARTWELL RX
[docInserts] => ["",""]
[products] => [{"drugName":"SPIRONOLACTONE","activeIngredients":"SPIRONOLACTONE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"SPIRONOLACTONE","submission":"SPIRONOLACTONE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)