Application Sponsors
ANDA 213530 | ECI PHARMS LLC | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | 5MG;2.5MG | 0 | CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-10-20 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
ECI PHARMS LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 213530
[companyName] => ECI PHARMS LLC
[docInserts] => ["",""]
[products] => [{"drugName":"CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE","activeIngredients":"CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE","strength":"5MG;2.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/20\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/21\/2020","submission":"SUPPL-1","supplementCategories":"","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-10-21
)
)