NDA 210303

CIPLA USA

FDA Drug Application

Application #210303

Documents

• Letter: 2018-06-26
• Label: 2018-06-26
• Review: 2018-07-27
• Letter: 2020-07-20

Application Sponsors

NDA 210303

CIPLA USA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

EQ 500MG BASE/10ML (EQ 50MG BASE/ML)

1

ZEMDRI

PLAZOMICIN SULFATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2018-06-25	PRIORITY
LABELING; Labeling	SUPPL	5	TA	2020-07-17	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	15

CDER Filings

CIPLA USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210303
            [companyName] => CIPLA USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZEMDRI","activeIngredients":"PLAZOMICIN SULFATE","strength":"EQ 500MG BASE\/10ML (EQ 50MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/25\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210303Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/25\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210303Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210303Orig1s000Ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210303Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/15\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210303Orig1s005ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-07-15
        )

)