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FDA NDA · NDA050624

ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER

Sponsor: HOFFMANN LA ROCHE

APPLICATION
NDA050624
TYPE
NDA
ORIGINAL APPROVAL
1987-02-11
LATEST ACTION
2004-09-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER · ReferenceDiscontinued
CEFTRIAXONE SODIUM EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER · ReferenceDiscontinued
CEFTRIAXONE SODIUM EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER · ReferenceDiscontinued
CEFTRIAXONE SODIUM EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2004-09-14Labeling · Supplement 27 · standard — Label ↗AP
2004-09-02Labeling · Supplement 26 · standard — Label ↗AP
2001-11-21Labeling · Supplement 21 · standardAP
1999-10-18Manufacturing (CMC) · Supplement 20 · standardAP
1997-07-21Manufacturing (CMC) · Supplement 19 · standardAP
1994-08-18Labeling · Supplement 17 · standardAP
1994-04-26Labeling · Supplement 15AP
1993-10-20Labeling · Supplement 18 · standardAP
1993-10-07Labeling · Supplement 11AP
1993-10-07Labeling · Supplement 12AP
1993-03-01Manufacturing (CMC) · Supplement 13 · standardAP
1993-02-22Labeling · Supplement 16 · standardAP
1992-12-04Labeling · Supplement 14AP
1991-04-15Manufacturing (CMC) · Supplement 5 · standardAP
1991-03-11Labeling · Supplement 8AP
1991-03-11Labeling · Supplement 6AP
1991-03-11Labeling · Supplement 9AP
1991-03-11Labeling · Supplement 10AP
1988-11-14Labeling · Supplement 7AP
1987-06-22Labeling · Supplement 2AP
1987-06-18Labeling · Supplement 4AP
1987-06-18Labeling · Supplement 3AP
1987-05-22Labeling · Supplement 1AP
1987-02-11Type 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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