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FDA NDA · NDA050585

ROCEPHIN KIT

Sponsor: HOFFMANN LA ROCHE

APPLICATION
NDA050585
TYPE
NDA
ORIGINAL APPROVAL
1984-12-21
LATEST ACTION
2018-07-12
ROUTE
INJECTION, INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ROCEPHIN KITDiscontinued
CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL,N/A, LIDOCAINE N/A,1% · INJECTABLE · INJECTION
ROCEPHIN · ReferenceDiscontinued
CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAMUSCULAR, INTRAVENOUS
ROCEPHIN · ReferenceDiscontinued
CEFTRIAXONE SODIUM EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAMUSCULAR, INTRAVENOUS
ROCEPHIN KITDiscontinued
CEFTRIAXONE SODIUM EQ 500MG BASE/VIAL,N/A, LIDOCAINE N/A,1% · INJECTABLE · INJECTION
ROCEPHIN · ReferenceDiscontinued
CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ROCEPHIN · ReferenceDiscontinued
CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAMUSCULAR, INTRAVENOUS
ROCEPHIN · ReferenceDiscontinued
CEFTRIAXONE SODIUM EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAMUSCULAR, INTRAVENOUS

Approval history

2018-07-12Labeling · Supplement 68 · standard — Label ↗AP
2015-06-30Labeling · Supplement 67 · standard — Label ↗AP
2015-03-20Labeling · Supplement 66 · standard — Letter ↗AP
2013-04-12Labeling · Supplement 65 · standard — Label ↗AP
2010-11-12Labeling · Supplement 62 · standard — Label ↗AP
2010-02-25Labeling · Supplement 64 · unknown — Label ↗AP
2009-06-07Labeling · Supplement 63 · standard — Label ↗AP
2009-03-11Labeling · Supplement 61 · standard — Label ↗AP
2008-08-18Labeling · Supplement 60 · standard — Label ↗AP
2008-08-18Labeling · Supplement 50 · standard — Label ↗AP
2007-07-17Labeling · Supplement 58 · standard — Letter ↗AP
2007-05-11Labeling · Supplement 59 · standard — Label ↗AP
2004-09-14Labeling · Supplement 57 · standard — Label ↗AP
2004-09-02Labeling · Supplement 56 · standard — Label ↗AP
2004-03-29Labeling · Supplement 54 · standard — Letter ↗AP
2000-08-25Labeling · Supplement 47 · standardAP
1999-10-18Manufacturing (CMC) · Supplement 49 · priorityAP
1998-04-28Manufacturing (CMC) · Supplement 48 · priorityAP
1997-12-23Efficacy · Supplement 46 · standardAP
1996-05-08Efficacy · Supplement 44 · standardAP
1996-03-14Manufacturing (CMC) · Supplement 37 · priorityAP
1995-09-14Labeling · Supplement 45 · standardAP
1994-08-18Labeling · Supplement 43 · standardAP
1994-04-26Labeling · Supplement 39AP
1994-02-04Manufacturing (CMC) · Supplement 42 · priorityAP
1993-10-07Labeling · Supplement 33AP
1993-05-28Efficacy · Supplement 34AP
1993-02-08Manufacturing (CMC) · Supplement 41 · priorityAP
1992-09-23Manufacturing (CMC) · Supplement 36 · priorityAP
1992-06-17Efficacy · Supplement 35AP
1992-02-11Efficacy · Supplement 23AP
1992-02-04Manufacturing (CMC) · Supplement 29 · priorityAP
1992-01-31Manufacturing (CMC) · Supplement 30 · priorityAP
1991-11-22Efficacy · Supplement 9AP
1991-09-12Manufacturing (CMC) · Supplement 31 · priorityAP
1991-03-11Labeling · Supplement 26AP
1991-03-11Labeling · Supplement 18AP
1991-03-11Manufacturing (CMC) · Supplement 25 · priorityAP
1990-12-31Efficacy · Supplement 27AP
1989-09-25Labeling · Supplement 15AP
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