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FDA NDA · NDA050551

CEFOBID

Sponsor: PFIZER

APPLICATION
NDA050551
TYPE
NDA
ORIGINAL APPROVAL
1982-11-18
LATEST ACTION
2025-03-03
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CEFOBIDDiscontinued
CEFOPERAZONE SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
CEFOBIDDiscontinued
CEFOPERAZONE SODIUM EQ 10GM BASE/VIAL · INJECTABLE · INJECTION
CEFOBIDDiscontinued
CEFOPERAZONE SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2025-03-03Labeling · Supplement 48 · standard — Letter ↗AP
2024-12-17Labeling · Supplement 47 · standard — Label ↗AP
2020-09-18Labeling · Supplement 46 · standard — Label ↗AP
2018-06-18Labeling · Supplement 44 · standard — Letter ↗AP
2017-09-28Labeling · Supplement 45 · standard — Label ↗AP
2015-03-18Labeling · Supplement 43 · standard — Label ↗AP
2002-12-18Labeling · Supplement 42 · standard — Letter ↗AP
2001-12-07Manufacturing (CMC) · Supplement 41 · standardAP
1994-10-28Labeling · Supplement 40 · standardAP
1990-03-05Labeling · Supplement 19AP
1988-09-29Labeling · Supplement 38AP
1982-11-18Type 1 - New Molecular Entity · 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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