Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 218454
Company: B BRAUN MEDICAL

Products on ANDA 218454

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIDAZOLAM IN 0.8% SODIUM CHLORIDE	MIDAZOLAM	50MG/50ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	No	Yes
MIDAZOLAM IN 0.8% SODIUM CHLORIDE	MIDAZOLAM	100MG/100ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218454

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/01/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.