ANDA 211908

GLAND PHARMA LTD

FDA Drug Application

Application #211908

Documents

• Letter: 2020-03-17

Application Sponsors

ANDA 211908

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAMUSCULAR

EQ 20MG BASE/ML

0

ZIPRASIDONE MESYLATE

ZIPRASIDONE MESYLATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-12-26	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-02-02	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211908
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZIPRASIDONE MESYLATE","activeIngredients":"ZIPRASIDONE MESYLATE","strength":"EQ 20MG BASE\/ML","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211908Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-26
        )

)