ANDA 078800

CIPLA

FDA Drug Application

Application #078800

Documents

• Letter: 2009-05-06

Application Sponsors

ANDA 078800

CIPLA

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	17	AP	2019-11-19	STANDARD
LABELING; Labeling	SUPPL	18	AP	2019-11-19	STANDARD
LABELING; Labeling	SUPPL	19	AP	2019-11-19	STANDARD
LABELING; Labeling	SUPPL	20	AP	2019-11-19	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	17	Null	7
SUPPL	18	Null	15
SUPPL	19	Null	15
SUPPL	20	Null	7

TE Codes

001

Prescription

AB

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78800
            [companyName] => CIPLA
            [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
        )

)