ANDA 212440

ALKEM LABS LTD

FDA Drug Application

Application #212440

Documents

• Letter: 2019-08-06

Application Sponsors

ANDA 212440

ALKEM LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

FOR SUSPENSION;ORAL

EQ 10MG BASE/ML

0

SILDENAFIL CITRATE

SILDENAFIL CITRATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-11-27	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212440
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SILDENAFIL CITRATE","activeIngredients":"SILDENAFIL CITRATE","strength":"EQ 10MG BASE\/ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/27\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212440Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-27
        )

)