Application Sponsors
| ANDA 211253 | PERRIGO UK FINCO | |
Marketing Status
Application Products
| 001 | GEL;TOPICAL | 1% | 0 | DICLOFENAC SODIUM | DICLOFENAC SODIUM |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2019-05-16 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2020-04-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2020-10-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2020-10-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2022-09-28 | UNKNOWN |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 14 | Null | 15 |
CDER Filings
PERRIGO UK FINCO
cder:Array
(
[0] => Array
(
[ApplNo] => 211253
[companyName] => PERRIGO UK FINCO
[docInserts] => ["",""]
[products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"1%","dosageForm":"GEL;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/16\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"04\/01\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-04-01
)
)