ANDA 211697

MACLEODS PHARMS LTD

FDA Drug Application

Application #211697

Application Sponsors

ANDA 211697

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

5%

0

LIDOCAINE

LIDOCAINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-03-16

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211697
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE","activeIngredients":"LIDOCAINE","strength":"5%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/16\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-16
        )

)