ANDA 207810

ALKEM LABS LTD

FDA Drug Application

Application #207810

Application Sponsors

ANDA 207810

ALKEM LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

5%

0

LIDOCAINE

LIDOCAINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-03-10	STANDARD
LABELING; Labeling	SUPPL	2	AP	2018-11-02	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001

Prescription

AT

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207810
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE","activeIngredients":"LIDOCAINE","strength":"5%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/10\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/02\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-11-02
        )

)