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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211263
Company: AREVA PHARMS

Products on ANDA 211263

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 211263

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/01/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/10/2024	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 211263

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
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	216506	HANGZHOU ZHONGMEI
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
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	216506	HANGZHOU ZHONGMEI
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	200833	HENGRUI PHARMA

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