ANDA 213349

AJANTA PHARMA LTD

FDA Drug Application

Application #213349

Application Sponsors

ANDA 213349

AJANTA PHARMA LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 2.5MG BASE	0	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE
002	TABLET;ORAL	EQ 5MG BASE	0	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE
003	TABLET;ORAL	EQ 10MG BASE	0	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE
004	TABLET;ORAL	EQ 20MG BASE	0	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-03-31

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

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

CDER Filings

AJANTA PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213349
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NEBIVOLOL HYDROCHLORIDE","submission":"NEBIVOLOL HYDROCHLORIDE","actionType":"EQ 2.5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NEBIVOLOL HYDROCHLORIDE","submission":"NEBIVOLOL HYDROCHLORIDE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NEBIVOLOL HYDROCHLORIDE","submission":"NEBIVOLOL HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NEBIVOLOL HYDROCHLORIDE","submission":"NEBIVOLOL HYDROCHLORIDE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)