APPLICATION
ANDA206086
TYPE
ANDA
ORIGINAL APPROVAL
2016-04-19
LATEST ACTION
2026-03-11
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MEROPENEMPrescription
MEROPENEM 1GM/VIAL · INJECTABLE · INJECTION
MEROPENEMPrescription
MEROPENEM 500MG/VIAL · INJECTABLE · INJECTION
Approval history
2026-03-11Labeling · Supplement 20 · standardAP
2026-03-11Labeling · Supplement 23 · standardAP
2026-03-11Labeling · Supplement 21 · standardAP
2016-04-19UNKNOWN · Original · 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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