FDA ANDA · ANDA061667

VANCOMYCIN HYDROCHLORIDE

Sponsor: ANI PHARMS

APPLICATION

ANDA061667

TYPE

ANDA

ORIGINAL APPROVAL

1983-07-13

LATEST ACTION

2021-01-29

ROUTE

ORAL

DOSAGE FORM

FOR SOLUTION

MARKETING STATUS

Prescription, Discontinued

Products

VANCOCIN HYDROCHLORIDEPrescription

VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML · FOR SOLUTION · ORAL

VANCOCIN HYDROCHLORIDEDiscontinued

VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/6ML · FOR SOLUTION · ORAL

2021-01-29Labeling · Supplement 27 · standardAP

2021-01-29Labeling · Supplement 28 · standardAP

2019-06-20Labeling · Supplement 26 · standard — Review ↗AP

1997-09-09Labeling · Supplement 23AP

1996-06-20Manufacturing (CMC) · Supplement 21AP

1993-07-29Labeling · Supplement 20AP

1991-07-12Labeling · Supplement 17AP

1991-05-17Labeling · Supplement 14AP

1983-07-13Original — Review ↗AP

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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