Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216081
Company: HENGRUI PHARMA

Products on ANDA 216081

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GADOBUTROL	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No
GADOBUTROL	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216081

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/08/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216081Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 216081

GADOBUTROL

SOLUTION;INTRAVENOUS; 18.1416GM/30ML (604.72MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GADAVIST	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	201277	BAYER HLTHCARE
GADOBUTROL	GADOBUTROL	18.1416GM/30ML (604.72MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216081	HENGRUI PHARMA

SOLUTION;INTRAVENOUS; 39.3068GM/65ML (604.72MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GADAVIST	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	201277	BAYER HLTHCARE
GADOBUTROL	GADOBUTROL	39.3068GM/65ML (604.72MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216081	HENGRUI PHARMA