ANDA 090092

HETERO LABS LTD III

FDA Drug Application

Application #090092

Documents

• Letter: 2008-04-28

Application Sponsors

ANDA 090092

HETERO LABS LTD III

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

300MG

0

ZIDOVUDINE

ZIDOVUDINE

FDA Submissions

	ORIG	1	AP	2008-04-25
LABELING; Labeling	SUPPL	2	AP	2010-02-25
LABELING; Labeling	SUPPL	6	AP	2020-02-10	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-02-10	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-02-10	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	1
SUPPL	6	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	7

TE Codes

001

Prescription

AB

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90092
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZIDOVUDINE","activeIngredients":"ZIDOVUDINE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZIDOVUDINE","submission":"ZIDOVUDINE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)