ANDA 077833

IMPAX LABS

FDA Drug Application

Application #077833

Documents

• Letter: 2007-04-09

Application Sponsors

ANDA 077833

IMPAX LABS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG;40MG	0	NADOLOL AND BENDROFLUMETHIAZIDE	BENDROFLUMETHIAZIDE; NADOLOL
002	TABLET;ORAL	5MG;80MG	0	NADOLOL AND BENDROFLUMETHIAZIDE	BENDROFLUMETHIAZIDE; NADOLOL

FDA Submissions

	ORIG	1	AP	2007-03-30
LABELING; Labeling	SUPPL	8	AP	2016-04-26	STANDARD

Submissions Property Types

SUPPL

8

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77833
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NADOLOL AND BENDROFLUMETHIAZIDE","activeIngredients":"BENDROFLUMETHIAZIDE; NADOLOL","strength":"5MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NADOLOL AND BENDROFLUMETHIAZIDE","activeIngredients":"BENDROFLUMETHIAZIDE; NADOLOL","strength":"5MG;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NADOLOL AND BENDROFLUMETHIAZIDE","submission":"BENDROFLUMETHIAZIDE; NADOLOL","actionType":"5MG;40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NADOLOL AND BENDROFLUMETHIAZIDE","submission":"BENDROFLUMETHIAZIDE; NADOLOL","actionType":"5MG;80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)