ANDA 212710

TEVA PHARMS USA

FDA Drug Application

Application #212710

Documents

• Letter: 2022-12-20

Application Sponsors

ANDA 212710

TEVA PHARMS USA

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

1%

0

PENCICLOVIR

PENCICLOVIR

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-11-09

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212710
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PENCICLOVIR","activeIngredients":"PENCICLOVIR","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/09\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-09
        )

)