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FDA NDA · NDA022106

DORIBAX

Sponsor: SHIONOGI

APPLICATION
NDA022106
TYPE
NDA
ORIGINAL APPROVAL
2007-10-12
LATEST ACTION
2015-11-13
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DORIBAX · ReferenceDiscontinued
DORIPENEM 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAVENOUS
DORIBAX · ReferenceDiscontinued
DORIPENEM 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAVENOUS

Approval history

2015-11-13Manufacturing (CMC) · Supplement 16 · standardAP
2015-08-10Labeling · Supplement 15 · standard — Label ↗AP
2014-01-17Labeling · Supplement 12 · standard — Letter ↗AP
2013-04-15Labeling · Supplement 8 · standard — Letter ↗AP
2013-04-15Labeling · Supplement 9 · standard — Label ↗AP
2013-04-15Labeling · Supplement 7 · standard — Label ↗AP
2013-04-15Labeling · Supplement 14 · standard — Label ↗AP
2012-01-26Labeling · Supplement 11 · standard — Label ↗AP
2009-04-16Labeling · Supplement 2 · standard — Letter ↗AP
2009-04-16Labeling · Supplement 5 · standard — Letter ↗AP
2009-02-11Labeling · Supplement 3 · standard — Label ↗AP
2007-10-12Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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