Application Sponsors
| ANDA 089424 | SUN PHARM INDUSTRIES | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 25MG | 0 | SPIRONOLACTONE | SPIRONOLACTONE |
| 002 | TABLET;ORAL | 50MG | 0 | SPIRONOLACTONE | SPIRONOLACTONE |
| 003 | TABLET;ORAL | 100MG | 0 | SPIRONOLACTONE | SPIRONOLACTONE |
FDA Submissions
| ORIG | 1 | AP | 1986-07-23 | |
| LABELING; Labeling | SUPPL | 2 | AP | 1988-04-29 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1989-01-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1990-11-08 | |
| LABELING; Labeling | SUPPL | 5 | AP | 1990-04-30 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1991-08-16 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1993-05-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1994-01-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1995-06-22 | |
| LABELING; Labeling | SUPPL | 10 | AP | 1996-02-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1996-07-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1996-12-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1996-12-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1997-02-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1997-12-05 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1998-07-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1998-12-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1999-08-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1999-08-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1999-08-11 | |
| LABELING; Labeling | SUPPL | 21 | AP | 1999-08-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1999-08-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2000-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2000-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2000-10-02 | |
| LABELING; Labeling | SUPPL | 26 | AP | 2000-10-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2001-07-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2002-02-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2002-06-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2002-06-05 | |
| LABELING; Labeling | SUPPL | 48 | AP | 2009-04-30 | |
| LABELING; Labeling | SUPPL | 49 | AP | 2012-01-23 | |
| LABELING; Labeling | SUPPL | 51 | AP | 2011-11-15 | |
| LABELING; Labeling | SUPPL | 52 | AP | 2014-09-22 | STANDARD |
| LABELING; Labeling | SUPPL | 53 | AP | 2014-09-22 | STANDARD |
| LABELING; Labeling | SUPPL | 55 | AP | 2015-09-22 | STANDARD |
| LABELING; Labeling | SUPPL | 58 | AP | 2019-07-25 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2021-03-08 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 49 | Null | 15 |
| SUPPL | 51 | Null | 15 |
| SUPPL | 52 | Null | 7 |
| SUPPL | 53 | Null | 7 |
| SUPPL | 55 | Null | 7 |
| SUPPL | 58 | Null | 15 |
| SUPPL | 62 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
SUN PHARM INDUSTRIES
cder:Array
(
[0] => Array
(
[ApplNo] => 89424
[companyName] => SUN PHARM INDUSTRIES
[docInserts] => ["",""]
[products] => [{"drugName":"SPIRONOLACTONE","activeIngredients":"SPIRONOLACTONE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SPIRONOLACTONE","activeIngredients":"SPIRONOLACTONE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SPIRONOLACTONE","activeIngredients":"SPIRONOLACTONE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"SPIRONOLACTONE","submission":"SPIRONOLACTONE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SPIRONOLACTONE","submission":"SPIRONOLACTONE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SPIRONOLACTONE","submission":"SPIRONOLACTONE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)