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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210274

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VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
EQ 500MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: POWDER; INTRAVENOUS, ORAL
Strength: EQ 500MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210274
Product Number: 001
Approval Date: Jan 20, 2023
Applicant Holder Full Name: ZHEJIANG NOVUS PHARMACEUTICALS CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
EQ 1GM BASE/VIAL
Marketing Status: Prescription
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: POWDER; INTRAVENOUS, ORAL
Strength: EQ 1GM BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210274
Product Number: 002
Approval Date: Jan 20, 2023
Applicant Holder Full Name: ZHEJIANG NOVUS PHARMACEUTICALS CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
EQ 5GM BASE/VIAL
Marketing Status: Prescription
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: POWDER; INTRAVENOUS, ORAL
Strength: EQ 5GM BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210274
Product Number: 003
Approval Date: Jan 20, 2023
Applicant Holder Full Name: ZHEJIANG NOVUS PHARMACEUTICALS CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
EQ 10GM BASE/VIAL
Marketing Status: Prescription
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: POWDER; INTRAVENOUS, ORAL
Strength: EQ 10GM BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210274
Product Number: 004
Approval Date: Jan 20, 2023
Applicant Holder Full Name: ZHEJIANG NOVUS PHARMACEUTICALS CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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