ANDA 216357

GLENMARK PHARMS LTD

FDA Drug Application

Application #216357

Application Sponsors

ANDA 216357

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	20MG	0	NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE
002	CAPSULE;ORAL	30MG	0	NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-12-16

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216357
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NICARDIPINE HYDROCHLORIDE","activeIngredients":"NICARDIPINE HYDROCHLORIDE","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NICARDIPINE HYDROCHLORIDE","activeIngredients":"NICARDIPINE HYDROCHLORIDE","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/16\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-16
        )

)