ANDA 207825

MYLAN PHARMS INC

FDA Drug Application

Application #207825

Application Sponsors

ANDA 207825

MYLAN PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, DELAYED RELEASE;ORAL

10MG;10MG

0

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-07-06

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207825
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE","activeIngredients":"DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE","strength":"10MG;10MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-06
        )

)