APPLICATION
ANDA065490
TYPE
ANDA
ORIGINAL APPROVAL
2012-04-09
LATEST ACTION
2024-03-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE · CAPSULE · ORAL
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE · CAPSULE · ORAL
Approval history
2024-03-06Labeling · Supplement 15 · standardAP
2024-03-06Labeling · Supplement 16 · standardAP
2024-03-06Labeling · Supplement 14 · standardAP
2019-05-03Manufacturing (CMC) · Supplement 10 · 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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