ANDA 078147

HIKMA PHARMS

FDA Drug Application

Application #078147

Documents

• Other Important Information from FDA: 2009-01-06

Application Sponsors

ANDA 078147

HIKMA PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	5MG	0	ZALEPLON	ZALEPLON
002	CAPSULE;ORAL	10MG	0	ZALEPLON	ZALEPLON

FDA Submissions

	ORIG	1	AP	2008-11-25
LABELING; Labeling	SUPPL	2	AP	2019-12-06	STANDARD

Submissions Property Types

SUPPL

2

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78147
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZALEPLON","activeIngredients":"ZALEPLON","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZALEPLON","activeIngredients":"ZALEPLON","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZALEPLON","submission":"ZALEPLON","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ZALEPLON","submission":"ZALEPLON","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)