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FDA ANDA · ANDA060180

VANCOCIN HYDROCHLORIDE

Sponsor: STERISCIENCE

APPLICATION
ANDA060180
TYPE
ANDA
ORIGINAL APPROVAL
1964-11-06
LATEST ACTION
2022-10-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

VANCOCIN HYDROCHLORIDEDiscontinued
VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
VANCOCIN HYDROCHLORIDEDiscontinued
VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2022-10-18Labeling · Supplement 50 · standardAP
2021-01-29Labeling · Supplement 49 · standard — Label ↗AP
2017-12-18Labeling · Supplement 48 · standard — Label ↗AP
2017-01-31Labeling · Supplement 47 · standard — Label ↗AP
2017-01-31Labeling · Supplement 46 · standardAP
1998-07-20Manufacturing (CMC) · Supplement 41AP
1996-07-01Manufacturing (CMC) · Supplement 37AP
1996-06-24Labeling · Supplement 39AP
1996-04-24Labeling · Supplement 38AP
1995-05-24Labeling · Supplement 32AP
1995-01-12Manufacturing (CMC) · Supplement 35AP
1995-01-12Manufacturing (CMC) · Supplement 34AP
1994-03-04Labeling · Supplement 33AP
1993-01-11Labeling · Supplement 31AP
1991-02-15Manufacturing (CMC) · Supplement 26AP
1990-04-10Manufacturing (CMC) · Supplement 27AP
1964-11-06OriginalAP
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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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