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FDA NDA · NDA050655

NAFCILLIN

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA050655
TYPE
NDA
ORIGINAL APPROVAL
1989-10-31
LATEST ACTION
2018-04-05
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

NALLPEN IN PLASTIC CONTAINER · ReferencePrescription
NAFCILLIN SODIUM EQ 2GM BASE/100ML · INJECTABLE · INJECTION
NALLPEN IN PLASTIC CONTAINER · ReferenceDiscontinued
NAFCILLIN SODIUM EQ 20MG BASE/ML · INJECTABLE · INJECTION

Approval history

2018-04-05Labeling · Supplement 26 · standard — Letter ↗AP
2017-07-14Labeling · Supplement 25 · standard — Letter ↗AP
2015-04-03Labeling · Supplement 23 · standard — Label ↗AP
2011-11-09Labeling · Supplement 18 · standard — Label ↗AP
2008-04-14Labeling · Supplement 17 · standard — Label ↗AP
2006-08-09Labeling · Supplement 16 · standard — Letter ↗AP
2003-08-07Labeling · Supplement 13 · standard — Letter ↗AP
2002-08-23Labeling · Supplement 12 · standard — Letter ↗AP
1998-08-07Manufacturing (CMC) · Supplement 11 · standardAP
1995-05-05Manufacturing (CMC) · Supplement 9 · standardAP
1995-04-03Manufacturing (CMC) · Supplement 8 · standardAP
1992-08-12Labeling · Supplement 7AP
1992-07-17Manufacturing (CMC) · Supplement 2 · standardAP
1992-03-25Manufacturing (CMC) · Supplement 6 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 3 · standardAP
1991-08-22Labeling · Supplement 1AP
1989-10-31Type 3 - New Dosage Form · Original · standardAP
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