ANDA 214065

ALKEM LABS LTD

FDA Drug Application

Application #214065

Documents

• Letter: 2021-01-12

Application Sponsors

ANDA 214065

ALKEM LABS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CAPSULE;ORAL

5MG;2.5MG

0

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE

CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-11-17

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214065
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORDIAZEPOXIDE HCL; CLIDINIUM BROMIDE","activeIngredients":"CHLORDIAZEPOXIDE HCL;CLIDINIUM BROMIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/17\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-17
        )

)