ANDA 212809

AJANTA PHARMA LTD

FDA Drug Application

Application #212809

Application Sponsors

ANDA 212809

AJANTA PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	12.5MG	0	CAPTOPRIL	CAPTOPRIL
002	TABLET;ORAL	25MG	0	CAPTOPRIL	CAPTOPRIL
003	TABLET;ORAL	50MG	0	CAPTOPRIL	CAPTOPRIL
004	TABLET;ORAL	100MG	0	CAPTOPRIL	CAPTOPRIL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-12-13

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

AJANTA PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212809
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CAPTOPRIL","activeIngredients":"CAPTOPRIL","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CAPTOPRIL","activeIngredients":"CAPTOPRIL","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CAPTOPRIL","activeIngredients":"CAPTOPRIL","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CAPTOPRIL","activeIngredients":"CAPTOPRIL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/13\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-13
        )

)