ANDA 206729

MICRO LABS LTD

FDA Drug Application

Application #206729

Application Sponsors

ANDA 206729

MICRO LABS LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004

Application Products

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

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-12-28

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MICRO LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206729
            [companyName] => MICRO LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/28\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-28
        )

)