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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206110
Company: FRESENIUS KABI USA

Products on NDA 206110

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 NDA 206110

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/2016	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Review	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206110lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206110Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206110Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206110Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/01/2021	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206110s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206110Orig1s003ltr.pdf
06/28/2018	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206110s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206110Orig1s001ltr.pdf

Labels for NDA 206110

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/01/2021	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206110s003lbl.pdf
06/28/2018	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206110s001lbl.pdf
06/28/2018	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206110s001lbl.pdf
12/30/2016	ORIG-1	Approval	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206110lbl.pdf

Therapeutic Equivalents for NDA 206110

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

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