Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217480
Company: HAINAN POLY PHARM

Products on ANDA 217480

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GADOBUTROL	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No
GADOBUTROL	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217480

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/15/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217480

GADOBUTROL

SOLUTION;INTRAVENOUS; 4.5354GM/7.5ML (604.72MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GADAVIST	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	201277	BAYER HLTHCARE
GADOBUTROL	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217480	HAINAN POLY PHARM
GADOBUTROL	GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215061	HENGRUI PHARMA

SOLUTION;INTRAVENOUS; 9.0708GM/15ML (604.72MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GADAVIST	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	201277	BAYER HLTHCARE
GADOBUTROL	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217480	HAINAN POLY PHARM
GADOBUTROL	GADOBUTROL	9.0708GM/15ML (604.72MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215061	HENGRUI PHARMA