Application Sponsors
| ANDA 203512 | ACCORD HLTHCARE | |
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
| UNKNOWN; | ORIG | 1 | AP | 2016-09-19 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-08-05 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-02-26 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 5 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
ACCORD HLTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 203512
[companyName] => ACCORD HLTHCARE
[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":"09\/19\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"08\/05\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-08-05
)
)