ANDA 078922

MYLAN PHARMS INC

FDA Drug Application

Application #078922

Documents

• Letter: 2008-02-19

Application Sponsors

ANDA 078922

MYLAN PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

300MG

0

ZIDOVUDINE

ZIDOVUDINE

FDA Submissions

	ORIG	1	AP	2008-02-14
LABELING; Labeling	SUPPL	4	AP	2011-03-02
LABELING; Labeling	SUPPL	5	AP	2012-03-30
LABELING; Labeling	SUPPL	9	AP	2015-06-26	STANDARD
LABELING; Labeling	SUPPL	10	AP	2015-06-26	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	4	Null	1
SUPPL	5	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78922
            [companyName] => MYLAN PHARMS INC
            [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
        )

)