Application Sponsors
| ANDA 206121 | UNIQUE PHARM LABS | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 5MG | 0 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 10MG | 0 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE |
| 003 | TABLET, EXTENDED RELEASE;ORAL | 15MG | 0 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2016-05-27 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-08-19 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-08-19 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2020-02-28 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
UNIQUE PHARM LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 206121
[companyName] => UNIQUE PHARM LABS
[docInserts] => ["",""]
[products] => [{"drugName":"OXYBUTYNIN CHLORIDE","activeIngredients":"OXYBUTYNIN CHLORIDE","strength":"5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYBUTYNIN CHLORIDE","activeIngredients":"OXYBUTYNIN CHLORIDE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYBUTYNIN CHLORIDE","activeIngredients":"OXYBUTYNIN CHLORIDE","strength":"15MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/27\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"02\/28\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/19\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/19\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-02-28
)
)