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FDA NDA · NDA050606

VANCOCIN

vancomycin hydrochloride

Sponsor: ANI PHARMS

APPLICATION
NDA050606
TYPE
NDA
ORIGINAL APPROVAL
1986-04-15
LATEST ACTION
2021-12-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

VANCOCIN HYDROCHLORIDE · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE · CAPSULE · ORAL
VANCOCIN HYDROCHLORIDE · ReferencePrescription
VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE · CAPSULE · ORAL

Approval history

2021-12-22Labeling · Supplement 39 · standard — Letter ↗AP
2021-01-29Labeling · Supplement 38 · standard — Label ↗AP
2020-08-11Labeling · Supplement 36 · standard — Letter ↗AP
2011-12-14Efficacy · Supplement 28 · standard — Label ↗AP
2010-01-08Labeling · Supplement 26 · standard — Letter ↗AP
2004-05-27Labeling · Supplement 20 · standard — Label ↗AP
2004-03-17Labeling · Supplement 19 · standard — Letter ↗AP
2004-03-17Supplement · Original · standardAP
2002-05-28Manufacturing (CMC) · Supplement 16 · standardAP
2002-05-24Labeling · Supplement 15 · standard — Letter ↗AP
2001-02-06Labeling · Supplement 14 · standardAP
1998-03-18Manufacturing (CMC) · Supplement 13 · standardAP
1997-05-12Labeling · Supplement 12 · standardAP
1996-06-14Labeling · Supplement 6AP
1996-06-14Labeling · Supplement 9AP
1995-09-27Labeling · Supplement 8AP
1993-06-30Labeling · Supplement 10 · standardAP
1988-05-23Labeling · Supplement 5AP
1987-08-18Manufacturing (CMC) · Supplement 4 · standardAP
1987-08-12Labeling · Supplement 3AP
1986-10-08Manufacturing (CMC) · Supplement 2 · standardAP
1986-06-05Labeling · Supplement 1AP
1986-04-15Type 3 - New Dosage Form · Original · standardAP
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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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