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FDA NDA · NDA208910

VANCOMYCIN HYDROCHLORIDE FOR ORAL SOLUTION

vancomycin hydrochloride

Sponsor: AZURITY

APPLICATION
NDA208910
TYPE
NDA
ORIGINAL APPROVAL
2018-01-26
LATEST ACTION
2022-02-16
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription

Products

FIRVANQ KIT · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML · FOR SOLUTION · ORAL
FIRVANQ KIT · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML · FOR SOLUTION · ORAL

Approval history

2022-02-16Labeling · Supplement 5 · standard — Letter ↗AP
2021-01-29Labeling · Supplement 7 · standard — Label ↗AP
2019-12-13Labeling · Supplement 4 · standard — Letter ↗AP
2018-01-26Type 5 - New Formulation or New Manufacturer · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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