Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212071
Company: EXELA PHARMA

Products on ANDA 212071

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CUPRIC CHLORIDE	CUPRIC CHLORIDE	EQ 0.4MG COPPER/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212071

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212071Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 212071

CUPRIC CHLORIDE

INJECTABLE;INJECTION; EQ 0.4MG COPPER/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CUPRIC CHLORIDE	CUPRIC CHLORIDE	EQ 0.4MG COPPER/ML	INJECTABLE;INJECTION	Prescription	No	AP	212071	EXELA PHARMA
CUPRIC CHLORIDE	CUPRIC CHLORIDE	EQ 0.4MG COPPER/ML	INJECTABLE;INJECTION	Prescription	No	AP	216113	SOMERSET
CUPRIC CHLORIDE	CUPRIC CHLORIDE	EQ 0.4MG COPPER/ML	INJECTABLE;INJECTION	Prescription	No	AP	217626	STIRA
CUPRIC CHLORIDE IN PLASTIC CONTAINER	CUPRIC CHLORIDE	EQ 0.4MG COPPER/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018960	HOSPIRA