Documents
Application Sponsors
ANDA 203689 | WATSON LABS TEVA | |
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | 0 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2017-07-12 | |
Submissions Property Types
CDER Filings
WATSON LABS TEVA
cder:Array
(
[0] => Array
(
[ApplNo] => 203689
[companyName] => WATSON LABS TEVA
[docInserts] => ["",""]
[products] => [{"drugName":"VARDENAFIL HYDROCHLORIDE","activeIngredients":"VARDENAFIL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/12\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203689Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-07-12
)
)