Application Sponsors
ANDA 205166 | HETERO LABS LTD V | |
Marketing Status
Application Products
001 | TABLET;ORAL | EQ 450MG BASE | 0 | VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-03-18 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2020-03-12 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2022-08-18 | STANDARD |
LABELING; Labeling | SUPPL | 14 | AP | 2022-08-18 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 6 | Null | 15 |
SUPPL | 13 | Null | 7 |
SUPPL | 14 | Null | 7 |
TE Codes
CDER Filings
HETERO LABS LTD V
cder:Array
(
[0] => Array
(
[ApplNo] => 205166
[companyName] => HETERO LABS LTD V
[docInserts] => ["",""]
[products] => [{"drugName":"VALGANCICLOVIR HYDROCHLORIDE","activeIngredients":"VALGANCICLOVIR HYDROCHLORIDE","strength":"EQ 450MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/18\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"03\/12\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-03-12
)
)