Application Sponsors
Marketing Status
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | 100MG | 0 | DICLOFENAC SODIUM | DICLOFENAC SODIUM |
FDA Submissions
| ORIG | 1 | AP | 2002-11-06 | |
LABELING; Labeling | SUPPL | 3 | AP | 2003-10-23 | |
LABELING; Labeling | SUPPL | 5 | AP | 2006-03-13 | |
LABELING; Labeling | SUPPL | 6 | AP | 2006-11-29 | |
LABELING; Labeling | SUPPL | 8 | AP | 2009-07-31 | |
LABELING; Labeling | SUPPL | 9 | AP | 2010-07-06 | |
LABELING; Labeling | SUPPL | 10 | AP | 2014-12-14 | |
LABELING; Labeling | SUPPL | 27 | AP | 2021-04-28 | STANDARD |
Submissions Property Types
SUPPL | 8 | Null | 7 |
SUPPL | 10 | Null | 8 |
SUPPL | 27 | Null | 15 |
TE Codes
CDER Filings
DEXCEL LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 76201
[companyName] => DEXCEL LTD
[docInserts] => ["",""]
[products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DICLOFENAC SODIUM","submission":"DICLOFENAC SODIUM","actionType":"100MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)