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FDA ANDA · ANDA062933

VANCOMYCIN HYDROCHLORIDE

Sponsor: HOSPIRA

APPLICATION
ANDA062933
TYPE
ANDA
ORIGINAL APPROVAL
1992-10-29
LATEST ACTION
2021-05-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL · INJECTABLE · INJECTION
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2021-05-24Labeling · Supplement 50 · standardAP
2020-09-01Labeling · Supplement 35 · standardAP
2020-09-01Labeling · Supplement 33 · standardAP
2020-09-01Labeling · Supplement 46 · standardAP
2020-09-01Labeling · Supplement 38 · standardAP
2015-11-03Labeling · Supplement 27AP
2012-06-12Labeling · Supplement 32 — Label ↗AP
2011-11-30Labeling · Supplement 21 — Label ↗AP
2009-05-27Labeling · Supplement 20AP
2002-03-15Manufacturing (CMC) · Supplement 5AP
2002-02-01Manufacturing (CMC) · Supplement 9AP
2001-06-14Manufacturing (CMC) · Supplement 8AP
2001-04-09Manufacturing (CMC) · Supplement 7AP
2000-04-04Manufacturing (CMC) · Supplement 6AP
1996-11-18Manufacturing (CMC) · Supplement 4AP
1995-10-25Manufacturing (CMC) · Supplement 3AP
1995-05-10Manufacturing (CMC) · Supplement 2AP
1993-04-09Manufacturing (CMC) · Supplement 1AP
1992-10-29OriginalAP
VIEW ON DRUGS@FDA ↗

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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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