ANDA 205318

TELIGENT PHARMA INC

FDA Drug Application

Application #205318

Documents

• Letter: 2016-02-03

Application Sponsors

ANDA 205318

TELIGENT PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

5%

0

LIDOCAINE

LIDOCAINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-02-01	STANDARD
LABELING; Labeling	SUPPL	3	AP	2018-11-02	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15

TE Codes

001

Prescription

AT

CDER Filings

TELIGENT PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205318
            [companyName] => TELIGENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE","activeIngredients":"LIDOCAINE","strength":"5%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/01\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205318Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/02\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/17\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-11-02
        )

)