APPLICATION
ANDA206141
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-08
LATEST ACTION
2025-08-21
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MEROPENEMPrescription
MEROPENEM 1GM/VIAL · INJECTABLE · INJECTION
MEROPENEMPrescription
MEROPENEM 500MG/VIAL · INJECTABLE · INJECTION
Approval history
2025-08-21Labeling · Supplement 15 · standardAP
2025-08-21Labeling · Supplement 13 · standardAP
2019-07-21Labeling · Supplement 4 · standardAP
2019-07-21Labeling · Supplement 2 · standardAP
2019-07-21Labeling · Supplement 5 · standardAP
2019-07-21Labeling · Supplement 3 · standardAP
2019-07-21Labeling · Supplement 1 · standardAP
2016-06-08UNKNOWN · 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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