Application Sponsors
| ANDA 207138 | ACCORD HLTHCARE | |
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 | 2016-02-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2017-01-05 | |
| LABELING; Labeling | SUPPL | 5 | AP | 2019-09-23 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
ACCORD HLTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 207138
[companyName] => ACCORD HLTHCARE
[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":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/29\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"09\/23\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/05\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/05\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-09-23
)
)