ANDA 077981

CIPLA LTD

FDA Drug Application

Application #077981

Documents

• Letter: 2008-07-01

Application Sponsors

ANDA 077981

CIPLA LTD

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

50MG/5ML

0

ZIDOVUDINE

ZIDOVUDINE

FDA Submissions

	ORIG	1	AP	2008-06-26
LABELING; Labeling	SUPPL	3	AP	2011-01-10
LABELING; Labeling	SUPPL	10	AP	2012-08-09	STANDARD
LABELING; Labeling	SUPPL	11	AP	2012-08-09	STANDARD
LABELING; Labeling	SUPPL	14	AP	2013-07-31	STANDARD
LABELING; Labeling	SUPPL	16	AP	2013-11-21	STANDARD
LABELING; Labeling	SUPPL	17	AP	2013-11-21	STANDARD
LABELING; Labeling	SUPPL	18	AP	2014-05-31
LABELING; Labeling	SUPPL	19	AP	2015-06-30	STANDARD
LABELING; Labeling	SUPPL	20	AP	2015-06-30	STANDARD
LABELING; Labeling	SUPPL	22	AP	2015-06-30	STANDARD
LABELING; Labeling	SUPPL	24	AP	2017-06-13	STANDARD
LABELING; Labeling	SUPPL	25	AP	2017-06-13	STANDARD
LABELING; Labeling	SUPPL	26	AP	2019-01-08	STANDARD
LABELING; Labeling	SUPPL	27	AP	2019-01-08	STANDARD
LABELING; Labeling	SUPPL	28	AP	2019-01-08	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	3	Null	1
SUPPL	10	Null	1
SUPPL	11	Null	15
SUPPL	14	Null	1
SUPPL	16	Null	15
SUPPL	17	Null	15
SUPPL	18	Null	15
SUPPL	19	Null	15
SUPPL	20	Null	15
SUPPL	22	Null	15
SUPPL	24	Null	15
SUPPL	25	Null	15
SUPPL	26	Null	15
SUPPL	27	Null	7
SUPPL	28	Null	7

TE Codes

001

Prescription

AA

CDER Filings

CIPLA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77981
            [companyName] => CIPLA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZIDOVUDINE","activeIngredients":"ZIDOVUDINE","strength":"50MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZIDOVUDINE","submission":"ZIDOVUDINE","actionType":"50MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)