Application Sponsors
ANDA 203047 | HETERO LABS LTD V | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | EQ 500MG BASE | 0 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE |
002 | TABLET;ORAL | EQ 1GM BASE | 0 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2015-04-08 | |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
HETERO LABS LTD V
cder:Array
(
[0] => Array
(
[ApplNo] => 203047
[companyName] => HETERO LABS LTD V
[docInserts] => ["",""]
[products] => [{"drugName":"VALACYCLOVIR HYDROCHLORIDE","activeIngredients":"VALACYCLOVIR HYDROCHLORIDE","strength":"EQ 500MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VALACYCLOVIR HYDROCHLORIDE","activeIngredients":"VALACYCLOVIR HYDROCHLORIDE","strength":"EQ 1GM BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/08\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/26\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2015-10-26
)
)