ANDA 205887

TELIGENT PHARMA INC

FDA Drug Application

Application #205887

Application Sponsors

ANDA 205887

TELIGENT PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

2.5%;2.5%

0

LIDOCAINE AND PRILOCAINE

LIDOCAINE; PRILOCAINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-06-29

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

TELIGENT PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205887
            [companyName] => TELIGENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE AND PRILOCAINE","activeIngredients":"LIDOCAINE; PRILOCAINE","strength":"2.5%;2.5%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/29\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/13\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-13
        )

)