ANDA 216067

ALKEM LABS LTD

FDA Drug Application

Application #216067

Application Sponsors

ANDA 216067

ALKEM LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	30MG	0	NIFEDIPINE	NIFEDIPINE
002	TABLET, EXTENDED RELEASE;ORAL	60MG	0	NIFEDIPINE	NIFEDIPINE
003	TABLET, EXTENDED RELEASE;ORAL	90MG	0	NIFEDIPINE	NIFEDIPINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2022-03-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2022-10-06	UNKNOWN

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001	Prescription	AB2
002	Prescription	AB2
003	Prescription	AB2

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216067
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NIFEDIPINE","activeIngredients":"NIFEDIPINE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NIFEDIPINE","activeIngredients":"NIFEDIPINE","strength":"60MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NIFEDIPINE","activeIngredients":"NIFEDIPINE","strength":"90MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/29\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-29
        )

)