ANDA 090636

HETERO LABS LTD III

FDA Drug Application

Application #090636

Documents

• Letter: 2010-04-05

Application Sponsors

ANDA 090636

HETERO LABS LTD III

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
UNKNOWN;	ORIG	2	AP	2018-01-26	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-01-23	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	9	Null	15

TE Codes

001

Prescription

AB

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90636
            [companyName] => HETERO LABS LTD III
            [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
        )

)