APPLICATION
ANDA065446
TYPE
ANDA
ORIGINAL APPROVAL
2009-09-15
LATEST ACTION
2017-12-04
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PIPERACILLIN AND TAZOBACTAMDiscontinued
PIPERACILLIN SODIUM EQ 36GM BASE/VIAL, TAZOBACTAM SODIUM EQ 4.5GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2017-12-04Labeling · Supplement 14 · standardAP
2017-12-04Labeling · Supplement 10 · standardAP
2017-12-04Labeling · Supplement 7 · standardAP
2017-12-04Labeling · Supplement 3AP
2017-12-04Labeling · Supplement 13 · standardAP
2017-12-04Labeling · Supplement 11 · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.