ANDA 215555

AMNEAL

FDA Drug Application

Application #215555

Application Sponsors

ANDA 215555

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

5MG;2.5MG

0

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE

CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-10-25

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215555
            [companyName] => AMNEAL
            [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\/25\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-25
        )

)