ANDA 090370

WATSON LABS INC

FDA Drug Application

Application #090370

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

ORIG	1	Null	7
SUPPL	9	Null	7

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
        )

)