Documents
Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | TABLET; ORAL | 200MG; 300MG | 0 | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
FDA Submissions
Submissions Property Types
TE Codes
CDER Filings
CIPLA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 90958
[companyName] => CIPLA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","strength":"200MG; 300MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","submission":"EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","actionType":"200MG; 300MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)