Application Sponsors
ANDA 090370 | WATSON LABS INC | |
Marketing Status
Discontinued | 001 |
Discontinued | 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
| ORIG | 1 | AP | 2011-03-16 | |
LABELING; Labeling | SUPPL | 9 | AP | 2020-03-12 | STANDARD |
Submissions Property Types
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 90370
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"VALACYCLOVIR HYDROCHLORIDE","activeIngredients":"VALACYCLOVIR HYDROCHLORIDE","strength":"EQ 500MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VALACYCLOVIR HYDROCHLORIDE","activeIngredients":"VALACYCLOVIR HYDROCHLORIDE","strength":"EQ 1GM BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"VALACYCLOVIR HYDROCHLORIDE","submission":"VALACYCLOVIR HYDROCHLORIDE","actionType":"EQ 500MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VALACYCLOVIR HYDROCHLORIDE","submission":"VALACYCLOVIR HYDROCHLORIDE","actionType":"EQ 1GM BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)