An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 200833
Company: HENGRUI PHARMA

Products on ANDA 200833

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200833

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/28/2018	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/02/2019	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 200833

CASPOFUNGIN ACETATE

POWDER;INTRAVENOUS; 50MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CANCIDAS	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	021227	MERCK
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	211263	AREVA PHARMS
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	206110	FRESENIUS KABI USA
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	207092	GLAND
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	200833	HENGRUI PHARMA

POWDER;INTRAVENOUS; 70MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CANCIDAS	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	021227	MERCK
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	211263	AREVA PHARMS
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	206110	FRESENIUS KABI USA
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	207092	GLAND
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	200833	HENGRUI PHARMA

Top