ANDA 202168

CADILA PHARMS LTD

FDA Drug Application

Application #202168

Application Sponsors

ANDA 202168

CADILA PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

	ORIG	1	AP	2013-11-15
LABELING; Labeling	SUPPL	2	AP	2020-12-23	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

CADILA PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202168
            [companyName] => CADILA PHARMS LTD
            [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":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/15\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-11-15
        )

)