FDA NDA · NDA050640

OXACILLIN

Sponsor: BAXTER HLTHCARE

APPLICATION

NDA050640

TYPE

NDA

ORIGINAL APPROVAL

1989-10-26

LATEST ACTION

2017-02-24

ROUTE

INTRAVENOUS, INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription, Discontinued

Products

BACTOCILL IN PLASTIC CONTAINER · ReferencePrescription

OXACILLIN SODIUM EQ 40MG BASE/ML · INJECTABLE · INJECTION

BACTOCILL IN PLASTIC CONTAINER · ReferenceDiscontinued

OXACILLIN SODIUM EQ 20MG BASE/ML · INJECTABLE · INJECTION

2017-02-24Labeling · Supplement 20 · standard — Label ↗AP

2015-01-06Labeling · Supplement 17 · standard — Label ↗AP

2014-02-19Manufacturing (CMC) · Supplement 9 · standardAP

2013-04-19Manufacturing (CMC) · Supplement 14 · standardAP

2012-11-21Labeling · Supplement 15 · standard — Letter ↗AP

2011-10-13Labeling · Supplement 11 · standard — Letter ↗AP

2008-04-17Labeling · Supplement 10 · standard — Letter ↗AP

2004-03-17Labeling · Supplement 7 · standard — Letter ↗AP

2002-08-23Labeling · Supplement 6 · standard — Letter ↗AP

2000-06-12Labeling · Supplement 4 · standardAP

1999-02-02Manufacturing (CMC) · Supplement 5 · standardAP

1993-04-05Manufacturing (CMC) · Supplement 2 · standardAP

1991-12-19Labeling · Supplement 1AP

1989-10-26Type 3 - New Dosage Form · Original · standardAP

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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