ANDA 214862

APOTEX INC

FDA Drug Application

Application #214862

Application Sponsors

ANDA 214862

APOTEX INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

002

TABLET; ORAL

10mg

0

OBETICHOLIC ACID

OBETICHOLIC ACID

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-06-14

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214862
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OBETICHOLIC ACID","activeIngredients":"OBETICHOLIC ACID","strength":"5mg","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"OBETICHOLIC ACID","activeIngredients":"OBETICHOLIC ACID","strength":"10mg","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/14\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-14
        )

)