ANDA 090561

CIPLA

FDA Drug Application

Application #090561

Documents

• Letter: 2010-11-03

Application Sponsors

ANDA 090561

CIPLA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

300MG

0

ZIDOVUDINE

ZIDOVUDINE

FDA Submissions

	ORIG	1	AP	2010-10-27
LABELING; Labeling	SUPPL	5	AP	2012-10-25	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-02-07	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-02-07	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-02-07	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-02-07	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-02-07	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	5	Null	1
SUPPL	7	Null	7
SUPPL	8	Null	15
SUPPL	10	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	7

TE Codes

001

Prescription

AB

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90561
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZIDOVUDINE","activeIngredients":"ZIDOVUDINE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZIDOVUDINE","submission":"ZIDOVUDINE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)