NDA 210649

MACLEODS PHARMS LTD

FDA Drug Application

Application #210649

Documents

• Label: 2019-03-19
• Letter: 2019-03-19
• Review: 2019-09-30
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01

Application Sponsors

NDA 210649

MACLEODS PHARMS LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

400MG;300MG;300MG

0

EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2019-03-15

PRIORITY

Submissions Property Types

ORIG

1

Null

7

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210649
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE","strength":"400MG;300MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/15\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210649s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/15\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210649s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210649Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/210649Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-03-15
        )

)