APPLICATION
NDA050580
TYPE
NDA
ORIGINAL APPROVAL
1986-12-31
LATEST ACTION
2021-04-16
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
AZACTAM · ReferencePrescription
AZTREONAM 1GM/VIAL · INJECTABLE · INJECTION
AZACTAM · ReferencePrescription
AZTREONAM 2GM/VIAL · INJECTABLE · INJECTION
AZACTAMDiscontinued
AZTREONAM 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2014-09-30Manufacturing (CMC) · Supplement 43 · priorityAP
2002-11-27Manufacturing (CMC) · Supplement 36 · priorityAP
2002-09-13Manufacturing (CMC) · Supplement 35 · priorityAP
2002-06-24Manufacturing (CMC) · Supplement 34 · priorityAP
1999-12-29Manufacturing (CMC) · Supplement 32 · priorityAP
1999-02-16Labeling · Supplement 31 · standardAP
1999-02-16Labeling · Supplement 28 · standardAP
1998-07-28Manufacturing (CMC) · Supplement 27 · priorityAP
1997-11-07Manufacturing (CMC) · Supplement 30 · priorityAP
1997-06-12Manufacturing (CMC) · Supplement 29 · priorityAP
1996-11-01Efficacy · Supplement 8AP
1996-08-20Labeling · Supplement 22AP
1996-08-20Labeling · Supplement 21AP
1996-04-03Manufacturing (CMC) · Supplement 26 · priorityAP
1994-05-23Manufacturing (CMC) · Supplement 25 · priorityAP
1994-05-23Manufacturing (CMC) · Supplement 23 · priorityAP
1993-02-18Manufacturing (CMC) · Supplement 24 · priorityAP
1992-06-25Labeling · Supplement 19AP
1991-09-30Labeling · Supplement 20AP
1990-09-18Manufacturing (CMC) · Supplement 17 · priorityAP
1989-04-10Manufacturing (CMC) · Supplement 18 · priorityAP
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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