ANDA 203834

HETERO LABS LTD V

FDA Drug Application

Application #203834

Application Sponsors

ANDA 203834

HETERO LABS LTD V

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	400MG	0	ACYCLOVIR	ACYCLOVIR
002	TABLET;ORAL	800MG	0	ACYCLOVIR	ACYCLOVIR

FDA Submissions

UNKNOWN;

ORIG

1

AP

2013-10-29

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] => 203834
            [companyName] => HETERO LABS LTD V
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACYCLOVIR","activeIngredients":"ACYCLOVIR","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ACYCLOVIR","activeIngredients":"ACYCLOVIR","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/29\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-10-29
        )

)