← FDA DRUG APPROVALS

FDA NDA · NDA050634

FORTAZ IN PLASTIC CONTAINER

Sponsor: PAI HOLDINGS PHARM

APPLICATION
NDA050634
TYPE
NDA
ORIGINAL APPROVAL
1989-04-28
LATEST ACTION
2017-07-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

FORTAZ IN PLASTIC CONTAINER · ReferenceDiscontinued
CEFTAZIDIME SODIUM EQ 40MG BASE/ML · INJECTABLE · INJECTION
FORTAZ IN PLASTIC CONTAINERDiscontinued
CEFTAZIDIME SODIUM EQ 10MG BASE/ML · INJECTABLE · INJECTION
FORTAZ IN PLASTIC CONTAINER · ReferenceDiscontinued
CEFTAZIDIME SODIUM EQ 20MG BASE/ML · INJECTABLE · INJECTION

Approval history

2017-07-28Labeling · Supplement 28 · standard — Label ↗AP
2014-09-24Labeling · Supplement 23 · standard — Label ↗AP
2014-04-11Manufacturing (CMC) · Supplement 27 · standardAP
2013-04-29Manufacturing (CMC) · Supplement 26 · standardAP
2007-07-09Labeling · Supplement 20 · standard — Label ↗AP
2007-03-14Labeling · Supplement 18 · standard — Label ↗AP
2004-05-19Labeling · Supplement 16 · standard — Label ↗AP
2002-03-29Labeling · Supplement 12 · standard — Label ↗AP
2002-03-22Labeling · Supplement 14 · standard — Letter ↗AP
2002-02-22Manufacturing (CMC) · Supplement 15 · standardAP
1998-01-26Labeling · Supplement 6 · standardAP
1997-11-25Manufacturing (CMC) · Supplement 11 · standardAP
1996-12-24Labeling · Supplement 10 · standardAP
1996-09-11Labeling · Supplement 9 · standardAP
1996-08-20Labeling · Supplement 5 · standardAP
1996-06-20Labeling · Supplement 7 · standardAP
1996-06-20Labeling · Supplement 8 · standardAP
1994-10-20Labeling · Supplement 4AP
1994-09-07Labeling · Supplement 1AP
1993-11-08Labeling · Supplement 3AP
1993-03-01Manufacturing (CMC) · Supplement 2 · standardAP
1989-04-28Type 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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