NDA 210274

ZHEJAING NOVUS PHARMACEUTICALS CO. LTD

FDA Drug Application

Application #210274

Documents

• Letter: 2023-01-23
• Label: 2023-01-24

Application Sponsors

NDA 210274

ZHEJAING NOVUS PHARMACEUTICALS CO. LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	INJECTABLE;INJECTION	500MG/VIAL	0	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
002	INJECTABLE;INJECTION	1GRAM/VIAL	0	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
003	INJECTABLE;INJECTION	5GRAM/VIAL	0	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
004	INJECTABLE;INJECTION	10GRAM/VIAL	0	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2023-01-20

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

ZHEJAING NOVUS PHARMACEUTICALS CO. LTD

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        (
            [ApplNo] => 210274
            [companyName] => ZHEJAING NOVUS PHARMACEUTICALS CO. LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"1GRAM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"5GRAM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"10GRAM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/20\/2023","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2023\\\/210274s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/20\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2023\\\/210274s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2023\\\/210274Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2023-01-20
        )

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