APPLICATION
ANDA205694
TYPE
ANDA
ORIGINAL APPROVAL
2016-01-21
LATEST ACTION
2023-06-06
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL · INJECTABLE · INJECTION
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL · INJECTABLE · INJECTION
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2023-06-06Manufacturing (CMC) · Supplement 11 · unknownAP
2022-07-28Labeling · Supplement 10 · standardAP
2020-08-19Labeling · Supplement 7 · standardAP
2020-08-19Labeling · Supplement 2 · standardAP
2016-01-21UNKNOWN · Original · standardAP
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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