APPLICATION
ANDA091404
TYPE
ANDA
ORIGINAL APPROVAL
2011-10-26
LATEST ACTION
2026-05-20
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MEROPENEMPrescription
MEROPENEM 1GM/VIAL · INJECTABLE · INJECTION
MEROPENEMPrescription
MEROPENEM 500MG/VIAL · INJECTABLE · INJECTION
Approval history
2026-05-20Labeling · Supplement 30 · standardAP
2026-05-20Labeling · Supplement 32 · standardAP
2019-07-21Labeling · Supplement 16 · standardAP
2019-07-21Labeling · Supplement 20 · standardAP
2019-07-21Labeling · Supplement 19 · standardAP
2019-07-21Labeling · Supplement 15 · standardAP
2019-07-21Labeling · Supplement 18 · standardAP
2015-07-22Labeling · Supplement 8 · standardAP
2015-07-22Labeling · Supplement 4 · standardAP
2015-07-22Labeling · Supplement 10 · standardAP
2015-07-22Labeling · Supplement 11 · standardAP
2014-11-10Manufacturing (CMC) · Supplement 7AP
2011-10-26OriginalAP
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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