Application Sponsors
| ANDA 090066 | UNIQUE PHARM LABS | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, DELAYED RELEASE;ORAL | 25MG | 0 | DICLOFENAC SODIUM | DICLOFENAC SODIUM |
| 002 | TABLET, DELAYED RELEASE;ORAL | 50MG | 0 | DICLOFENAC SODIUM | DICLOFENAC SODIUM |
FDA Submissions
| ORIG | 1 | AP | 2010-12-01 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2014-10-22 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-05-09 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2021-03-29 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2021-04-28 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 12 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
UNIQUE PHARM LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 90066
[companyName] => UNIQUE PHARM LABS
[docInserts] => ["",""]
[products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"25MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"50MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DICLOFENAC SODIUM","submission":"DICLOFENAC SODIUM","actionType":"25MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DICLOFENAC SODIUM","submission":"DICLOFENAC SODIUM","actionType":"50MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)