ANDA 208040

ALKEM LABS LTD

FDA Drug Application

Application #208040

Documents

• Letter: 2020-05-14

Application Sponsors

ANDA 208040

ALKEM LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	EQ 75MG BASE	0	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE
002	CAPSULE;ORAL	EQ 150MG BASE	0	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-03-11	STANDARD
UNKNOWN;	ORIG	2	TA	2020-03-11	STANDARD

Submissions Property Types

ORIG	1	Null	15
ORIG	2	Null	29

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208040
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DABIGATRAN ETEXILATE MESYLATE","activeIngredients":"DABIGATRAN ETEXILATE MESYLATE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DABIGATRAN ETEXILATE MESYLATE","activeIngredients":"DABIGATRAN ETEXILATE MESYLATE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/11\/2020","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/11\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208040Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-11
        )

)