ANDA 202346

MYLAN TECHNOLOGIES

FDA Drug Application

Application #202346

Documents

• Review: 2019-01-14

Application Sponsors

ANDA 202346

MYLAN TECHNOLOGIES

Marketing Status

• Prescription: 001

Application Products

001

PATCH;TOPICAL

5%

0

LIDOCAINE

LIDOCAINE

FDA Submissions

	ORIG	1	AP	2015-08-07
LABELING; Labeling	SUPPL	12	AP	2019-10-02	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	12	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MYLAN TECHNOLOGIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202346
            [companyName] => MYLAN TECHNOLOGIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE","activeIngredients":"LIDOCAINE","strength":"5%","dosageForm":"PATCH;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/07\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/202346Orig1s000.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/02\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-02
        )

)