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FDA NDA · NDA050671

VANCOMYCIN HYDROCHLORIDE

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA050671
TYPE
NDA
ORIGINAL APPROVAL
1993-04-29
LATEST ACTION
2026-06-09
ROUTE
INTRAVITREAL, INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) · SOLUTION · INTRAVENOUS
VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/200ML (EQ 5MG BASE/ML) · SOLUTION · INTRAVENOUS
VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/100ML (EQ 5MG BASE/ML) · SOLUTION · INTRAVENOUS
VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) · SOLUTION · INTRAVENOUS
VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/150ML (EQ 5MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-06-09Labeling · Supplement 43 · standard — Letter ↗AP
2025-05-29Labeling · Supplement 36 · standard — Letter ↗AP
2024-06-07Labeling · Supplement 32 · standard — Letter ↗AP
2021-01-29Labeling · Supplement 31 · standard — Label ↗AP
2017-09-28Labeling · Supplement 24 · standard — Label ↗AP
2017-01-09Labeling · Supplement 23 · standard — Label ↗AP
2015-12-18Manufacturing (CMC) · Supplement 22 · standard — Letter ↗AP
2015-11-13Manufacturing (CMC) · Supplement 21 · standardAP
2012-01-17Labeling · Supplement 18 · unknown — Letter ↗AP
2009-03-11Labeling · Supplement 14 · standard — Label ↗AP
2008-05-02Labeling · Supplement 12 · standard — Label ↗AP
2007-09-17Labeling · Supplement 10 · standard — Label ↗AP
2004-03-30Labeling · Supplement 6 · standard — Letter ↗AP
1999-03-01Manufacturing (CMC) · Supplement 5 · standardAP
1998-01-08Labeling · Supplement 4 · standard — Review ↗AP
1998-01-08Efficacy · Supplement 2 · standard — Review ↗AP
1997-11-07Manufacturing (CMC) · Supplement 3 · standardAP
1996-07-30Manufacturing (CMC) · Supplement 1 · standardAP
1993-04-29Type 3 - New Dosage Form · 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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