APPLICATION
ANDA216154
TYPE
ANDA
ORIGINAL APPROVAL
2022-08-18
LATEST ACTION
2025-12-11
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MEROPENEMPrescription
MEROPENEM 500MG/VIAL · INJECTABLE · INJECTION
MEROPENEMPrescription
MEROPENEM 1GM/VIAL · INJECTABLE · INJECTION
Approval history
2025-12-11Labeling · Supplement 2 · standardAP
2025-03-13Labeling · Supplement 1 · standardAP
2022-08-18UNKNOWN · 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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