ANDA 212444

MACLEODS PHARMS LTD

FDA Drug Application

Application #212444

Application Sponsors

ANDA 212444

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

5%

0

ACYCLOVIR

ACYCLOVIR

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-05-19

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212444
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACYCLOVIR","activeIngredients":"ACYCLOVIR","strength":"5%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/19\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-19
        )

)