Documents
Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 150MG;200MG;300MG | 1 | LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE | LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE |
FDA Submissions
TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2018-08-13 | STANDARD |
Submissions Property Types
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
)
)