Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217737
Company: AMNEAL

Products on ANDA 217737

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IOHEXOL	IOHEXOL	64.7%	SOLUTION;INJECTION, ORAL, RECTAL	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217737

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/13/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217737Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 217737

IOHEXOL

SOLUTION;INJECTION, ORAL, RECTAL; 64.7%
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IOHEXOL	IOHEXOL	64.7%	SOLUTION;INJECTION, ORAL, RECTAL	Prescription	No	AP	217737	AMNEAL
OMNIPAQUE 300	IOHEXOL	64.7%	SOLUTION;INJECTION, ORAL, RECTAL	Prescription	Yes	AP	018956	GE HEALTHCARE