Documents
Application Sponsors
ANDA 203053 | HETERO LABS LTD V | |
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | TABLET; ORAL | 600MG; 200MG; 300MG | 0 | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2013-10-31 | |
Submissions Property Types
TE Codes
CDER Filings
HETERO LABS LTD V
cder:Array
(
[0] => Array
(
[ApplNo] => 203053
[companyName] => HETERO LABS LTD V
[docInserts] => ["",""]
[products] => [{"drugName":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","strength":"600MG; 200MG; 300MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/31\/2013","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203053Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2013-10-31
)
)