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FDA NDA · NDA050823

CEFTAZIDIME IN DEXTROSE CONTAINER

Sponsor: B BRAUN

APPLICATION
NDA050823
TYPE
NDA
ORIGINAL APPROVAL
2011-06-13
LATEST ACTION
2021-10-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CEFTAZIDIME IN DEXTROSE CONTAINER · ReferenceDiscontinued
CEFTAZIDIME EQ 2GM BASE · INJECTABLE · INJECTION
CEFTAZIDIME IN DEXTROSE CONTAINER · ReferenceDiscontinued
CEFTAZIDIME EQ 1GM BASE · INJECTABLE · INJECTION

Approval history

2021-10-20Labeling · Supplement 9 · standard — Label ↗AP
2019-07-29Labeling · Supplement 7 · standard — Letter ↗AP
2015-05-15Labeling · Supplement 4 · standard — Label ↗AP
2014-04-01Manufacturing (CMC) · Supplement 3 · standardAP
2011-06-13Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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