ANDA 090742

STRIDES PHARMA

FDA Drug Application

Application #090742

Application Sponsors

ANDA 090742

STRIDES PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

300MG

0

TENOFOVIR DISOPROXIL FUMARATE

TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

	ORIG	1	AP	2018-01-26
LABELING; Labeling	SUPPL	6	TA	2016-12-07	STANDARD
LABELING; Labeling	SUPPL	8	TA	2016-12-07	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-11-19	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	6	Null	31
SUPPL	8	Null	31
SUPPL	12	Null	7

TE Codes

001

Prescription

AB

CDER Filings

STRIDES PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90742
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"TENOFOVIR DISOPROXIL FUMARATE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TENOFOVIR DISOPROXIL FUMARATE","submission":"TENOFOVIR DISOPROXIL FUMARATE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)