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FDA NDA · NDA209776

VABOMERE

meropenem-vaborbactam

Sponsor: REMPEX

APPLICATION
NDA209776
TYPE
NDA
ORIGINAL APPROVAL
2017-08-29
LATEST ACTION
2026-02-20
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

VABOMERE · ReferencePrescription
MEROPENEM 1GM/VIAL, VABORBACTAM 1GM/VIAL · POWDER · INTRAVENOUS

Approval history

2026-02-20Labeling · Supplement 10 · standard — Letter ↗AP
2024-12-03Labeling · Supplement 9 · standard — Letter ↗AP
2023-09-21Labeling · Supplement 4 · standard — Letter ↗AP
2020-05-25Labeling · Supplement 3 · standard — Letter ↗AP
2018-07-06Labeling · Supplement 1 · standard — Label ↗AP
2017-08-29Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Label ↗AP
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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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