← FDA DRUG APPROVALS

FDA NDA · NDA211962

TYZAVAN

vancomycin

Sponsor: HIKMA

APPLICATION
NDA211962
TYPE
NDA
ORIGINAL APPROVAL
2019-02-15
LATEST ACTION
2025-06-27
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

TYZAVAN · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) · SOLUTION · INTRAVENOUS
TYZAVAN · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 2GM BASE/400ML (EQ 5MG BASE/ML) · SOLUTION · INTRAVENOUS
TYZAVAN · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/200ML (EQ 5MG BASE/ML) · SOLUTION · INTRAVENOUS
TYZAVAN · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) · SOLUTION · INTRAVENOUS
TYZAVAN · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/150ML (EQ 5MG BASE/ML) · SOLUTION · INTRAVENOUS
TYZAVAN · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) · SOLUTION · INTRAVENOUS
TYZAVAN · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/100ML (EQ 5MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-06-27Efficacy · Supplement 17 · standard — Letter ↗AP
2025-06-26Labeling · Supplement 14 · standard — Letter ↗AP
2021-05-28Efficacy · Supplement 9 · standard — Letter ↗AP
2021-01-29Labeling · Supplement 11 · standard — Label ↗AP
2020-09-03Labeling · Supplement 3 · standard — Letter ↗AP
2019-02-15Type 5 - New Formulation or New Manufacturer · Original · priority — 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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