ANDA 091168

CIPLA

FDA Drug Application

Application #091168

Documents

• Letter: 2011-04-01
• Letter: 2018-08-16

Application Sponsors

ANDA 091168

CIPLA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

200MG

0

EMTRICITABINE

EMTRICITABINE

FDA Submissions

	ORIG	1	AP	2018-07-02
LABELING; Labeling	SUPPL	7	AP	2020-01-22	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	7	Null	7

TE Codes

001

Prescription

AB

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91168
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMTRICITABINE","activeIngredients":"EMTRICITABINE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"EMTRICITABINE","submission":"EMTRICITABINE","actionType":"200MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)