ANDA 212472

ACTAVIS LABS FL INC

FDA Drug Application

Application #212472

Documents

• Letter: 2022-08-03

Application Sponsors

ANDA 212472

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

20MG;20MG

0

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-03-01

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212472
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE","activeIngredients":"DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE","strength":"20MG;20MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/01\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-01
        )

)