ANDA 203047

HETERO LABS LTD V

FDA Drug Application

Application #203047

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

ORIG

1

Null

15

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
        )

)