Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214271
Company: HENGRUI PHARMA

Products on ANDA 214271

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IODIXANOL	IODIXANOL	55%	INJECTABLE;INJECTION	Prescription	AP	No	No
IODIXANOL	IODIXANOL	65.2%	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214271

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/19/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214271Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/27/2025	SUPPL-15	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
12/19/2024	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 214271

IODIXANOL

INJECTABLE;INJECTION; 55%
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IODIXANOL	IODIXANOL	55%	INJECTABLE;INJECTION	Prescription	No	AP	214271	HENGRUI PHARMA
VISIPAQUE 270	IODIXANOL	55%	INJECTABLE;INJECTION	Prescription	Yes	AP	020351	GE HEALTHCARE

INJECTABLE;INJECTION; 65.2%
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IODIXANOL	IODIXANOL	65.2%	INJECTABLE;INJECTION	Prescription	No	AP	214271	HENGRUI PHARMA
VISIPAQUE 320	IODIXANOL	65.2%	INJECTABLE;INJECTION	Prescription	Yes	AP	020351	GE HEALTHCARE