Documents
Application Sponsors
NDA 022464 | STRIDES ARCOLAB LTD | |
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | TABLET; ORAL | 150MG; 200MG; 300MG | 0 | LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE | LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE |
FDA Submissions
TYPE 4; Type 4 - New Combination | ORIG | 1 | TA | 2009-12-22 | STANDARD |
Submissions Property Types
CDER Filings
STRIDES ARCOLAB LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 22464
[companyName] => STRIDES ARCOLAB LTD
[docInserts] => ["",""]
[products] => [{"drugName":"LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE","activeIngredients":"LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE","strength":"150MG; 200MG; 300MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE","submission":"LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE","actionType":"150MG; 200MG; 300MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)