ANDA 077505

CIPLA LTD

FDA Drug Application

Application #077505

Documents

• Other Important Information from FDA: 2008-07-01

Application Sponsors

ANDA 077505

CIPLA LTD

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	2008-06-20
LABELING; Labeling	SUPPL	2	AP	2019-11-04	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-11-04	STANDARD

Submissions Property Types

SUPPL	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

CIPLA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77505
            [companyName] => CIPLA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZALEPLON","activeIngredients":"ZALEPLON","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZALEPLON","activeIngredients":"ZALEPLON","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZALEPLON","submission":"ZALEPLON","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ZALEPLON","submission":"ZALEPLON","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)