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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 210274


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NDA 210274 describes VANCOMYCIN HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Usa, Lupin Ltd, Orient Pharma Co Ltd, Pai Holdings Pharm, Strides Pharma, Watson Labs, Alkem Labs Ltd, Amneal, Aspiro, Avet Lifesciences, Eugia Pharma, Gland Pharma Ltd, Hainan Poly, Hainan Poly Pharm, Hikma, Hikma Pharms, Hospira, Hospira Inc, Knack, Medimetriks Pharms, Meitheal, Mylan Labs Ltd, Sagent Pharms, Sandoz, Sandoz Inc, Teva Pharms Usa, Xellia Pharms Aps, Zhejiang Novus Pharm, Samson Medcl, and Baxter Hlthcare, and is included in fifty-three NDAs. It is available from twenty-five suppliers. There are five patents protecting this drug. Additional details are available on the VANCOMYCIN HYDROCHLORIDE profile page.

The generic ingredient in VANCOMYCIN HYDROCHLORIDE is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 210274
Pharmacology for NDA: 210274
Medical Subject Heading (MeSH) Categories for 210274
Suppliers and Packaging for NDA: 210274
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride POWDER;INTRAVENOUS, ORAL 210274 NDA HIKMA PHARMACEUTICALS USA INC. 0143-9161 0143-9161-25 25 VIAL in 1 PACKAGE (0143-9161-25) / 513 mg in 1 VIAL (0143-9161-01)
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride POWDER;INTRAVENOUS, ORAL 210274 NDA HIKMA PHARMACEUTICALS USA INC. 0143-9162 0143-9162-10 10 VIAL in 1 PACKAGE (0143-9162-10) / 1025 mg in 1 VIAL (0143-9162-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUS, ORALStrengthEQ 500MG BASE/VIAL
Approval Date:Jan 20, 2023TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUS, ORALStrengthEQ 1GM BASE/VIAL
Approval Date:Jan 20, 2023TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUS, ORALStrengthEQ 5GM BASE/VIAL
Approval Date:Jan 20, 2023TE:RLD:Yes

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