Application 212819

Related Records

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RECARBRIO	CILASTATIN SODIUM; IMIPENEM; RELEBACTAM	POWDER;INTRAVENOUS	EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL	Yes	Yes

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-3856	RECARBRIO	imipenem anhydrous, cilastatin, and relebactam anhydrous	Merck Sharp & Dohme Corp.	NDA	Current
0006-3856	RECARBRIO	imipenem anhydrous, cilastatin, and relebactam anhydrous	Merck Sharp & Dohme Corp.	NDA	Current
0006-3856	RECARBRIO	imipenem anhydrous, cilastatin, and relebactam anhydrous	Merck Sharp & Dohme Corp.	NDA	Current
0006-3856	RECARBRIO	imipenem anhydrous, cilastatin, and relebactam anhydrous	Merck Sharp & Dohme LLC	NDA	Current
0006-3856	RECARBRIO	imipenem anhydrous, cilastatin, and relebactam anhydrous	Merck Sharp & Dohme Corp.	NDA	Current