ANDA 078349

CIPLA LTD

FDA Drug Application

Application #078349

Documents

• Letter: 2007-05-29

Application Sponsors

ANDA 078349

CIPLA LTD

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

100MG

0

ZIDOVUDINE

ZIDOVUDINE

FDA Submissions

	ORIG	1	AP	2007-05-23
LABELING; Labeling	SUPPL	5	AP	2009-03-27
LABELING; Labeling	SUPPL	8	AP	2011-05-04
LABELING; Labeling	SUPPL	11	AP	2011-10-31
LABELING; Labeling	SUPPL	12	AP	2012-01-20
LABELING; Labeling	SUPPL	14	AP	2012-08-08	STANDARD
LABELING; Labeling	SUPPL	18	AP	2015-11-19	STANDARD
LABELING; Labeling	SUPPL	20	AP	2017-06-28	STANDARD
LABELING; Labeling	SUPPL	21	AP	2017-06-28	STANDARD
LABELING; Labeling	SUPPL	22	AP	2019-01-04	STANDARD
LABELING; Labeling	SUPPL	23	AP	2019-01-04	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	5	Null	1
SUPPL	8	Null	1
SUPPL	11	Null	1
SUPPL	12	Null	1
SUPPL	14	Null	1
SUPPL	18	Null	15
SUPPL	20	Null	7
SUPPL	21	Null	15
SUPPL	22	Null	15
SUPPL	23	Null	15

TE Codes

001

Prescription

AB

CDER Filings

CIPLA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78349
            [companyName] => CIPLA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZIDOVUDINE","activeIngredients":"ZIDOVUDINE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZIDOVUDINE","submission":"ZIDOVUDINE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)