ANDA 076588

SUN PHARM INDS LTD

FDA Drug Application

Application #076588

Application Sponsors

ANDA 076588

SUN PHARM INDS LTD

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

	ORIG	1	AP	2007-01-31
LABELING; Labeling	SUPPL	6	AP	2010-07-20
LABELING; Labeling	SUPPL	12	AP	2010-07-20
LABELING; Labeling	SUPPL	13	AP	2010-07-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2018-02-16
LABELING; Labeling	SUPPL	19	AP	2013-05-14	STANDARD
LABELING; Labeling	SUPPL	21	AP	2020-02-28	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	6	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	16	Null	7
SUPPL	19	Null	15
SUPPL	21	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76588
            [companyName] => SUN PHARM INDS LTD
            [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":"VALACYCLOVIR HYDROCHLORIDE","submission":"VALACYCLOVIR HYDROCHLORIDE","actionType":"EQ 500MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"VALACYCLOVIR HYDROCHLORIDE","submission":"VALACYCLOVIR HYDROCHLORIDE","actionType":"EQ 1GM BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)