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RECARBRIO (nda212819)- (EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL)

CILASTATIN SODIUM; IMIPENEM; RELEBACTAM MSD MERCK CO
EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL
No No
2033-Mar-21 2024-Jul-16
None None
None No
RECARBRIO is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a betalactamase inhibitor, indicated in patients 18 years of age and older for the treatment of the following infections caused by susceptible gram-negative microorganisms:  Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP)  Complicated urinary tract infections, including pyelonephritis (cUTI) in patients who have limited or no alternative treatment options.  Complicated intra-abdominal infections (cIAI) in patients who have limited or no alternative treatment options
0 0 0
Total Other Developers None
Drugs with Suitability No
EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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