ANDA 203828

INDCHEMIE HEALTH

FDA Drug Application

Application #203828

Application Sponsors

ANDA 203828

INDCHEMIE HEALTH

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 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	2015-07-29
LABELING; Labeling	SUPPL	3	AP	2021-11-19	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	3	Null	15

TE Codes

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

CDER Filings

INDCHEMIE HEALTH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203828
            [companyName] => INDCHEMIE HEALTH
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/29\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-07-29
        )

)