APPLICATION
ANDA090439
TYPE
ANDA
ORIGINAL APPROVAL
2015-01-28
LATEST ACTION
2023-11-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
VANCOMYCIN HYDROCHLORIDEDiscontinued
VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE · CAPSULE · ORAL
VANCOMYCIN HYDROCHLORIDEDiscontinued
VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE · CAPSULE · ORAL
Approval history
2023-11-03Labeling · Supplement 6 · standardAP
2023-11-03Labeling · Supplement 4 · standardAP
2023-11-03Labeling · Supplement 2 · standardAP
2023-11-03Labeling · Supplement 5 · standardAP
2023-11-03Labeling · Supplement 1 · standardAP
2015-01-28OriginalAP
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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