Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218749
Company: HAINAN POLY

Products on ANDA 218749

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GADOTERIDOL	GADOTERIDOL	279.3MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218749

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/11/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218749Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 218749

GADOTERIDOL

INJECTABLE;INJECTION; 279.3MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GADOTERIDOL	GADOTERIDOL	279.3MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	218749	HAINAN POLY
PROHANCE	GADOTERIDOL	279.3MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020131	BRACCO