APPLICATION
ANDA062663
TYPE
ANDA
ORIGINAL APPROVAL
1987-03-17
LATEST ACTION
2021-05-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL · INJECTABLE · INJECTION
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL · INJECTABLE · INJECTION
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL · INJECTABLE · INJECTION
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2021-05-24Labeling · Supplement 94 · standardAP
2020-08-27Labeling · Supplement 86 · standardAP
2020-08-27Labeling · Supplement 90 · standardAP
2017-07-12Labeling · Supplement 85 · standardAP
2017-07-12Labeling · Supplement 83 · standardAP
2016-02-16Labeling · Supplement 55AP
2016-02-16Labeling · Supplement 42AP
2016-02-16Labeling · Supplement 57AP
2002-12-05Manufacturing (CMC) · Supplement 37AP
2002-12-02Manufacturing (CMC) · Supplement 35AP
2002-12-02Manufacturing (CMC) · Supplement 36AP
2001-10-18Manufacturing (CMC) · Supplement 32AP
2000-12-13Manufacturing (CMC) · Supplement 29AP
2000-12-13Manufacturing (CMC) · Supplement 27AP
2000-12-13Manufacturing (CMC) · Supplement 26AP
2000-12-13Manufacturing (CMC) · Supplement 30AP
2000-09-11Manufacturing (CMC) · Supplement 28AP
2000-02-01Manufacturing (CMC) · Supplement 24AP
1999-10-25Manufacturing (CMC) · Supplement 23AP
1999-10-18Manufacturing (CMC) · Supplement 22AP
1998-02-11Manufacturing (CMC) · Supplement 21AP
1997-11-28Manufacturing (CMC) · Supplement 19AP
1997-11-28Labeling · Supplement 20AP
1996-07-05Manufacturing (CMC) · Supplement 18AP
1996-03-12Labeling · Supplement 17AP
1995-04-03Labeling · Supplement 16AP
1994-11-30Manufacturing (CMC) · Supplement 13AP
1994-11-30Manufacturing (CMC) · Supplement 14AP
1992-08-04Labeling · Supplement 15AP
1991-12-23Manufacturing (CMC) · Supplement 8AP
1991-06-07Manufacturing (CMC) · Supplement 9AP
1990-11-20Labeling · Supplement 10AP
1988-08-11Manufacturing (CMC) · Supplement 7AP
1988-06-03Manufacturing (CMC) · Supplement 4AP
1987-03-17OriginalAP
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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