ANDA 213361

AUROBINDO PHARMA LTD

FDA Drug Application

Application #213361

Application Sponsors

ANDA 213361

AUROBINDO PHARMA 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

2021-07-19

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB1
002	Prescription	AB1
003	Prescription	AB1

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213361
            [companyName] => AUROBINDO PHARMA 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":"07\/19\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-19
        )

)