ANDA 203126

TWI PHARMS

FDA Drug Application

Application #203126

Application Sponsors

ANDA 203126

TWI 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	2014-04-03
LABELING; Labeling	SUPPL	2	AP	2015-11-24	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001	Prescription	AB2
002	Prescription	AB2
003	Prescription	AB2

CDER Filings

TWI PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203126
            [companyName] => TWI 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":"04\/03\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/24\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/24\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-11-24
        )

)