Application Sponsors
ANDA 060574 | DELCOR ASSET CORP | |
Marketing Status
Application Products
001 | TABLET;ORAL | 500,000 UNITS | 0 | MYCOSTATIN | NYSTATIN |
FDA Submissions
| ORIG | 1 | AP | 1964-09-16 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1992-06-23 | |
LABELING; Labeling | SUPPL | 12 | AP | 1992-12-07 | |
LABELING; Labeling | SUPPL | 13 | AP | 1996-04-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1995-11-27 | |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
CDER Filings
DELCOR ASSET CORP
cder:Array
(
[0] => Array
(
[ApplNo] => 60574
[companyName] => DELCOR ASSET CORP
[docInserts] => ["",""]
[products] => [{"drugName":"MYCOSTATIN","activeIngredients":"NYSTATIN","strength":"500,000 UNITS","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"MYCOSTATIN","submission":"NYSTATIN","actionType":"500,000 UNITS","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)