APPLICATION
ANDA205780
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-31
LATEST ACTION
2020-08-17
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2020-08-17Labeling · Supplement 2 · standardAP
2020-08-17Labeling · Supplement 1 · standardAP
2016-03-31UNKNOWN · 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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