← FDA DRUG APPROVALS

FDA NDA · NDA212819

RECARBRIO

imipenem anhydrous, cilastatin, and relebactam anhydrous

Sponsor: MSD MERCK CO

APPLICATION
NDA212819
TYPE
NDA
ORIGINAL APPROVAL
2019-07-16
LATEST ACTION
2025-12-09
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

RECARBRIO · ReferencePrescription
CILASTATIN SODIUM EQ 500MG BASE/VIAL, IMIPENEM 500MG/VIAL, RELEBACTAM 250MG/VIAL · POWDER · INTRAVENOUS

Approval history

2025-12-09Efficacy · Supplement 8 · standard — Letter ↗AP
2020-06-04Efficacy · Supplement 2 · priority — Label ↗AP
2019-07-16Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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