Documents
Application Sponsors
| ANDA 074286 | TARO PHARM INDS LTD | |
Marketing Status
Application Products
| 001 | OINTMENT;TOPICAL | 0.25% | 0 | TOPICORT | DESOXIMETASONE |
FDA Submissions
| ORIG | 1 | AP | 1996-06-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1997-07-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1999-04-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2000-05-16 | |
| LABELING; Labeling | SUPPL | 6 | AP | 2003-12-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2004-04-26 | |
| LABELING; Labeling | SUPPL | 8 | AP | 2004-04-26 | |
| LABELING; Labeling | SUPPL | 9 | AP | 2004-11-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2005-09-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2008-07-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2008-07-25 | |
| LABELING; Labeling | SUPPL | 15 | AP | 2015-04-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2010-03-15 | |
| LABELING; Labeling | SUPPL | 17 | AP | 2013-03-20 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 15 | Null | 7 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 15 |
TE Codes
CDER Filings
TARO PHARM INDS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 74286
[companyName] => TARO PHARM INDS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"TOPICORT","activeIngredients":"DESOXIMETASONE","strength":"0.25%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
[labels] => [{"actionDate":"03\/20\/2013","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/074286Orig1s017lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"TOPICORT","submission":"DESOXIMETASONE","actionType":"0.25%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2013-03-20
)
)