ANDA 208702

PERRIGO UK FINCO

FDA Drug Application

Application #208702

Documents

• Letter: 2019-03-12
• Review: 2021-12-20

Application Sponsors

ANDA 208702

PERRIGO UK FINCO

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

5%

0

ACYCLOVIR

ACYCLOVIR

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-02-04	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-11-02	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO UK FINCO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208702
            [companyName] => PERRIGO UK FINCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACYCLOVIR","activeIngredients":"ACYCLOVIR","strength":"5%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/04\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208702Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-04
        )

)