ANDA 211891

ALKEM LABS LTD

FDA Drug Application

Application #211891

Documents

• Letter: 2020-03-17

Application Sponsors

ANDA 211891

ALKEM LABS LTD

Marketing Status

• None (Tentative Approval): 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	30MG	0	TOLVAPTAN	TOLVAPTAN
002	TABLET;ORAL	60MG	0	TOLVAPTAN	TOLVAPTAN
003	TABLET;ORAL	15MG	0	TOLVAPTAN	TOLVAPTAN

FDA Submissions

UNKNOWN;	ORIG	1	TA	2020-01-30	STANDARD
UNKNOWN;	ORIG	2	TA	2020-05-19	STANDARD

Submissions Property Types

ORIG	1	Null	31
ORIG	2	Null	31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211891
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOLVAPTAN","activeIngredients":"TOLVAPTAN","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TOLVAPTAN","activeIngredients":"TOLVAPTAN","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/19\/2020","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/19\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211891Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-19
        )

)