APPLICATION
ANDA065439
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-18
LATEST ACTION
2021-11-29
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AZTREONAMPrescription
AZTREONAM 2GM/VIAL · INJECTABLE · INJECTION
AZTREONAMPrescription
AZTREONAM 500MG/VIAL · INJECTABLE · INJECTION
AZTREONAMPrescription
AZTREONAM 1GM/VIAL · INJECTABLE · INJECTION
Approval history
2021-11-29Labeling · Supplement 9 · standardAP
2021-11-29Labeling · Supplement 14 · standardAP
2015-04-28Labeling · Supplement 5 · standardAP
2015-04-28Labeling · Supplement 4 · standardAP
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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