ANDA 208766

AMNEAL

FDA Drug Application

Application #208766

Application Sponsors

ANDA 208766

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

5%

0

ACYCLOVIR

ACYCLOVIR

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-11-09	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-11-01	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208766
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACYCLOVIR","activeIngredients":"ACYCLOVIR","strength":"5%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-09
        )

)