ANDA 091593

CIPLA LIMITED

FDA Drug Application

Application #091593

Documents

• Letter: 2012-02-29

Application Sponsors

ANDA 091593

CIPLA LIMITED

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

001	TABLET; ORAL	600MG	0	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
002	TABLET; ORAL	200MG	0	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
003	TABLET; ORAL	300MG	0	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

N/A; Not Applicable	ORIG	1	TA	2012-02-27
LABELING; Labeling	SUPPL	19	TA	2017-09-05	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	19	Null	31

CDER Filings

CIPLA LIMITED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91593
            [companyName] => CIPLA LIMITED
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","strength":"600MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","strength":"200MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","strength":"300MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","submission":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","actionType":"600MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","submission":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","actionType":"200MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","submission":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","actionType":"300MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)