Application Sponsors
ANDA 077863 | UNIQUE PHARM LABS | |
Marketing Status
Application Products
003 | TABLET, DELAYED RELEASE;ORAL | 75MG | 0 | DICLOFENAC SODIUM | DICLOFENAC SODIUM |
FDA Submissions
| ORIG | 1 | AP | 2007-06-08 | |
LABELING; Labeling | SUPPL | 3 | AP | 2009-08-04 | |
LABELING; Labeling | SUPPL | 5 | AP | 2011-03-17 | |
LABELING; Labeling | SUPPL | 6 | AP | 2014-10-22 | |
LABELING; Labeling | SUPPL | 8 | AP | 2016-05-09 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2021-03-29 | STANDARD |
LABELING; Labeling | SUPPL | 17 | AP | 2021-04-28 | STANDARD |
Submissions Property Types
SUPPL | 3 | Null | 7 |
SUPPL | 6 | Null | 7 |
SUPPL | 8 | Null | 7 |
SUPPL | 10 | Null | 7 |
SUPPL | 17 | Null | 7 |
TE Codes
CDER Filings
UNIQUE PHARM LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 77863
[companyName] => UNIQUE PHARM LABS
[docInserts] => ["",""]
[products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"75MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DICLOFENAC SODIUM","submission":"DICLOFENAC SODIUM","actionType":"75MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)