Documents
Application Sponsors
NDA 018763 | TARO PHARM INDS LTD | |
Marketing Status
Application Products
001 | OINTMENT;TOPICAL | 0.25% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | TOPICORT | DESOXIMETASONE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1983-10-03 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2004-04-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1993-10-13 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1994-07-26 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1996-01-19 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1996-01-25 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1998-02-18 | STANDARD |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 9 | Null | 0 |
CDER Filings
TARO PHARM INDS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 18763
[companyName] => TARO PHARM INDS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"TOPICORT","activeIngredients":"DESOXIMETASONE","strength":"0.25% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"04\/27\/2004","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/18763slr003_topicort_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"TOPICORT","submission":"DESOXIMETASONE","actionType":"0.25% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2004-04-27
)
)