ANDA 210012

ZYDUS PHARMS

FDA Drug Application

Application #210012

Application Sponsors

ANDA 210012

ZYDUS PHARMS

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	2017-12-19	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-08-11	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

TE Codes

001	Prescription	AB2
002	Prescription	AB2
003	Prescription	AB2

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210012
            [companyName] => ZYDUS PHARMS
            [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":"12\/19\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-19
        )

)