Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 217583
Company: FRESENIUS KABI USA

Products on ANDA 217583

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MANGANESE CHLORIDE	MANGANESE CHLORIDE	EQ 0.1MG MANGANESE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217583

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/07/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217583

MANGANESE CHLORIDE

INJECTABLE;INJECTION; EQ 0.1MG MANGANESE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MANGANESE CHLORIDE	MANGANESE CHLORIDE	EQ 0.1MG MANGANESE/ML	INJECTABLE;INJECTION	Prescription	No	AP	217583	FRESENIUS KABI USA
MANGANESE CHLORIDE IN PLASTIC CONTAINER	MANGANESE CHLORIDE	EQ 0.1MG MANGANESE/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018962	HOSPIRA