ANDA 213366

ANNORA PHARMA

FDA Drug Application

Application #213366

Application Sponsors

ANDA 213366

ANNORA PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 5MG BASE	0	IVABRADINE HYDROCHLORIDE	IVABRADINE HYDROCHLORIDE
002	TABLET;ORAL	EQ 7.5MG BASE	0	IVABRADINE HYDROCHLORIDE	IVABRADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-10-05

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ANNORA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213366
            [companyName] => ANNORA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IVABRADINE HYDROCHLORIDE","activeIngredients":"IVABRADINE HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IVABRADINE HYDROCHLORIDE","activeIngredients":"IVABRADINE HYDROCHLORIDE","strength":"EQ 7.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/05\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-05
        )

)