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FDA NDA · NDA209481

VANCOMYCIN HYDROCHLORIDE

Sponsor: MYLAN LABS LTD

APPLICATION
NDA209481
TYPE
NDA
ORIGINAL APPROVAL
2018-07-10
LATEST ACTION
2024-06-26
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription, Discontinued

Products

VANCOMYCIN HYDROCHLORIDE · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 2GM BASE/VIAL · POWDER · INTRAVENOUS
VANCOMYCIN HYDROCHLORIDE · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL · POWDER · INTRAVENOUS
VANCOMYCIN HYDROCHLORIDE · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL · POWDER · INTRAVENOUS
VANCOMYCIN HYDROCHLORIDE · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 1.75GM BASE/VIAL · POWDER · INTRAVENOUS
VANCOMYCIN HYDROCHLORIDE · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/VIAL · POWDER · INTRAVENOUS
VANCOMYCIN HYDROCHLORIDE · ReferenceDiscontinued
VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · POWDER · INTRAVENOUS

Approval history

2024-06-26Efficacy · Supplement 24 — Letter ↗AP
2022-04-04Labeling · Supplement 16 · standard — Letter ↗AP
2021-01-29Labeling · Supplement 12 · standard — Label ↗AP
2019-08-09Labeling · Supplement 5 · standard — Label ↗AP
2018-07-10Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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