ANDA 213957

ZYDUS

FDA Drug Application

Application #213957

Application Sponsors

ANDA 213957

ZYDUS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	12.5MG	0	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE
002	TABLET;ORAL	25MG	0	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-06-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

ZYDUS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213957
            [companyName] => ZYDUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/23\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-23
        )

)