← FDA DRUG APPROVALS

FDA NDA · NDA050578

FORTAZ

Sponsor: PAI HOLDINGS PHARM

APPLICATION
NDA050578
TYPE
NDA
ORIGINAL APPROVAL
1985-07-19
LATEST ACTION
2020-02-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

FORTAZ · ReferenceDiscontinued
CEFTAZIDIME 6GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
FORTAZ · ReferenceDiscontinued
CEFTAZIDIME 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
FORTAZ · ReferenceDiscontinued
CEFTAZIDIME 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
FORTAZ · ReferenceDiscontinued
CEFTAZIDIME 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2020-02-12Labeling · Supplement 62 · standard — Letter ↗AP
2020-02-11Labeling · Supplement 64 · standard — Letter ↗AP
2017-07-28Labeling · Supplement 61 · standard — Label ↗AP
2015-03-03Manufacturing (CMC) · Supplement 60 · priorityAP
2014-09-24Labeling · Supplement 55 · standard — Label ↗AP
2007-07-09Labeling · Supplement 53 · standard — Letter ↗AP
2007-03-14Labeling · Supplement 51 · standard — Label ↗AP
2004-05-19Labeling · Supplement 46 · standard — Label ↗AP
2002-10-23Manufacturing (CMC) · Supplement 44 · priorityAP
2002-03-29Labeling · Supplement 40 · standard — Letter ↗AP
2002-03-22Labeling · Supplement 42 · standard — Letter ↗AP
2002-02-22Manufacturing (CMC) · Supplement 43 · priorityAP
1998-01-26Labeling · Supplement 32 · standardAP
1997-11-25Manufacturing (CMC) · Supplement 39 · priorityAP
1997-04-03Manufacturing (CMC) · Supplement 38 · priorityAP
1996-12-24Labeling · Supplement 37 · standardAP
1996-10-04Manufacturing (CMC) · Supplement 36 · priorityAP
1996-09-11Labeling · Supplement 30 · standardAP
1996-08-20Labeling · Supplement 31 · standardAP
1996-06-20Labeling · Supplement 33 · standardAP
1996-06-20Labeling · Supplement 34 · standardAP
1995-11-03Manufacturing (CMC) · Supplement 35 · priorityAP
1994-10-20Labeling · Supplement 27AP
1994-09-07Labeling · Supplement 22AP
1993-04-29Labeling · Supplement 17AP
1993-04-29Labeling · Supplement 15AP
1993-02-18Manufacturing (CMC) · Supplement 29 · priorityAP
1992-12-31Labeling · Supplement 28AP
1992-02-13Manufacturing (CMC) · Supplement 21 · priorityAP
1992-02-13Manufacturing (CMC) · Supplement 24 · priorityAP
1991-08-09Manufacturing (CMC) · Supplement 26 · priorityAP
1990-04-10Manufacturing (CMC) · Supplement 18 · priorityAP
1990-03-22Manufacturing (CMC) · Supplement 20 · priorityAP
1985-07-19Type 1 - New Molecular Entity · Original · priority — 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →