Application Sponsors
ANDA 211362 | WINDER LABS LLC | |
Marketing Status
Application Products
001 | TABLET;ORAL | 0.025MG;2.5MG | 0 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-01-27 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
WINDER LABS LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 211362
[companyName] => WINDER LABS LLC
[docInserts] => ["",""]
[products] => [{"drugName":"DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE","strength":"0.025MG;2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/27\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-01-27
)
)