ANDA 078556

IMPAX LABS

FDA Drug Application

Application #078556

Application Sponsors

ANDA 078556

IMPAX LABS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	0.125MG	0	DIGOXIN	DIGOXIN
002	TABLET;ORAL	0.25MG	0	DIGOXIN	DIGOXIN

FDA Submissions

	ORIG	1	AP	2009-07-20
LABELING; Labeling	SUPPL	2	AP	2010-04-26
LABELING; Labeling	SUPPL	5	AP	2015-04-06
LABELING; Labeling	SUPPL	10	AP	2015-04-06	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-11-12	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-11-12	STANDARD
LABELING; Labeling	SUPPL	21	AP	2020-11-12	STANDARD
LABELING; Labeling	SUPPL	22	AP	2020-11-12	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	5	Null	15
SUPPL	10	Null	31
SUPPL	13	Null	7
SUPPL	18	Null	15
SUPPL	21	Null	15
SUPPL	22	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78556
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIGOXIN","activeIngredients":"DIGOXIN","strength":"0.125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DIGOXIN","activeIngredients":"DIGOXIN","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIGOXIN","submission":"DIGOXIN","actionType":"0.125MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DIGOXIN","submission":"DIGOXIN","actionType":"0.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)