ANDA 091036

HIKMA PHARMS

FDA Drug Application

Application #091036

Application Sponsors

ANDA 091036

HIKMA PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	FOR SUSPENSION;ORAL	EQ 250MG BASE/5ML	0	CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE
002	FOR SUSPENSION;ORAL	EQ 500MG BASE/5ML	0	CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE

FDA Submissions

	ORIG	1	AP	2012-11-28
LABELING; Labeling	SUPPL	4	AP	2015-12-17	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-12-17	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91036
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFADROXIL","activeIngredients":"CEFADROXIL\/CEFADROXIL HEMIHYDRATE","strength":"EQ 250MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFADROXIL","activeIngredients":"CEFADROXIL\/CEFADROXIL HEMIHYDRATE","strength":"EQ 500MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFADROXIL","submission":"CEFADROXIL\/CEFADROXIL HEMIHYDRATE","actionType":"EQ 250MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFADROXIL","submission":"CEFADROXIL\/CEFADROXIL HEMIHYDRATE","actionType":"EQ 500MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)