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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 206110

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NDA 206110 describes CASPOFUNGIN ACETATE, which is a drug marketed by Areva Pharms, Cipla, Fresenius Kabi Usa, Gland, Hengrui Pharma, Norvium Bioscience, and Xellia Pharms Aps, and is included in seven NDAs. It is available from seven suppliers. There is one patent protecting this drug. Additional details are available on the CASPOFUNGIN ACETATE profile page.

The generic ingredient in CASPOFUNGIN ACETATE is caspofungin acetate. There are eight drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the caspofungin acetate profile page.

Summary for 206110

Tradename:	CASPOFUNGIN ACETATE
Applicant:	Fresenius Kabi Usa
Ingredient:	caspofungin acetate
Patents:	1

Pharmacology for NDA: 206110

Suppliers and Packaging for NDA: 206110

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	206110	NDA	Fresenius Kabi USA, LLC	63323-356	63323-356-10	10 VIAL, SINGLE-DOSE in 1 CARTON (63323-356-10) / 10.8 mL in 1 VIAL, SINGLE-DOSE (63323-356-01)
CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	206110	NDA	Fresenius Kabi USA, LLC	63323-358	63323-358-10	10 VIAL, SINGLE-DOSE in 1 CARTON (63323-358-10) / 10.8 mL in 1 VIAL, SINGLE-DOSE (63323-358-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	50MG/VIAL
Approval Date:	Dec 30, 2016	TE:	AP	RLD:	No
Patent:	9,636,407	Patent Expiration:	Dec 21, 2032	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	70MG/VIAL
Approval Date:	Dec 30, 2016	TE:	AP	RLD:	No
Patent:	9,636,407	Patent Expiration:	Dec 21, 2032	Product Flag?	Y	Substance Flag?		Delist Request?

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