ANDA 079128

STRIDES PHARMA

FDA Drug Application

Application #079128

Application Sponsors

ANDA 079128

STRIDES PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

150MG;300MG

0

LAMIVUDINE AND ZIDOVUDINE

LAMIVUDINE; ZIDOVUDINE

FDA Submissions

	ORIG	1	AP	2015-05-13
LABELING; Labeling	SUPPL	13	AP	2019-07-16	STANDARD
LABELING; Labeling	SUPPL	14	AP	2019-07-16	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	13	Null	7
SUPPL	14	Null	7

TE Codes

001

Prescription

AB

CDER Filings

STRIDES PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79128
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE AND ZIDOVUDINE","activeIngredients":"LAMIVUDINE; ZIDOVUDINE","strength":"150MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LAMIVUDINE AND ZIDOVUDINE","submission":"LAMIVUDINE; ZIDOVUDINE","actionType":"150MG;300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)