MICRO LABS FDA Approval NDA 205626

NDA 205626

MICRO LABS

FDA Drug Application

Application #205626

Documents

Label2018-08-15
Medication Guide2018-08-15
Letter2018-08-20
Review2018-11-26
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01

Application Sponsors

NDA 205626MICRO LABS

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL150MG;200MG;300MG1LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINELAMIVUDINE; NEVIRAPINE; ZIDOVUDINE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2018-08-13STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

MICRO LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205626
            [companyName] => MICRO LABS
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/205626s000lbl.pdf#page=50"]
            [products] => [{"drugName":"LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE","activeIngredients":"LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE","strength":"150MG;200MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/13\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205626s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/13\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205626s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205626Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/205626Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-08-13
        )

)

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