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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218538
Company: RK PHARMA

Products on ANDA 218538

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHROMIC CHLORIDE	CHROMIC CHLORIDE	EQ 0.004MG CHROMIUM/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218538

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/18/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218538

CHROMIC CHLORIDE

INJECTABLE;INJECTION; EQ 0.004MG CHROMIUM/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CHROMIC CHLORIDE	CHROMIC CHLORIDE	EQ 0.004MG CHROMIUM/ML	INJECTABLE;INJECTION	Prescription	No	AP	218538	RK PHARMA
CHROMIC CHLORIDE IN PLASTIC CONTAINER	CHROMIC CHLORIDE	EQ 0.004MG CHROMIUM/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018961	HOSPIRA

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