ANDA 216019

PHARMADAX INC

FDA Drug Application

Application #216019

Application Sponsors

ANDA 216019

PHARMADAX INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-11-18

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB2
002	Prescription	AB2

CDER Filings

PHARMADAX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216019
            [companyName] => PHARMADAX INC
            [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"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-18
        )

)