Documents
Application Sponsors
NDA 207369 | HETERO LABS LTD V | |
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | TABLET;ORAL | 60MG;30MG | 2 | ABACAVIR; LAMIVUDINE | ABACAVIR;LAMIVUDINE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | TA | 2015-11-13 | STANDARD |
Submissions Property Types
CDER Filings
HETERO LABS LTD V
cder:Array
(
[0] => Array
(
[ApplNo] => 207369
[companyName] => HETERO LABS LTD V
[docInserts] => ["",""]
[products] => [{"drugName":"ABACAVIR; LAMIVUDINE","activeIngredients":"ABACAVIR;LAMIVUDINE","strength":"60MG;30MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"TBD","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/13\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/207369Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2015-11-13
)
)