ANDA 077002

HIKMA INTL PHARMS

FDA Drug Application

Application #077002

Application Sponsors

ANDA 077002

HIKMA INTL PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

	ORIG	1	AP	2007-10-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2015-02-23
LABELING; Labeling	SUPPL	6	AP	2011-12-30
LABELING; Labeling	SUPPL	9	AP	2016-11-12	STANDARD
LABELING; Labeling	SUPPL	11	AP	2016-11-12	STANDARD
LABELING; Labeling	SUPPL	12	AP	2016-11-12	STANDARD
LABELING; Labeling	SUPPL	15	AP	2020-10-07	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-10-07	STANDARD
LABELING; Labeling	SUPPL	22	AP	2020-10-07	STANDARD

Submissions Property Types

SUPPL	4	Null	7
SUPPL	6	Null	7
SUPPL	9	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	15	Null	15
SUPPL	20	Null	7
SUPPL	22	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77002
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIGOXIN","activeIngredients":"DIGOXIN","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DIGOXIN","activeIngredients":"DIGOXIN","strength":"0.125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIGOXIN","submission":"DIGOXIN","actionType":"0.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DIGOXIN","submission":"DIGOXIN","actionType":"0.125MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)