Details for New Drug Application (NDA): 207092

NDA 207092 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 207092

Tradename:	CASPOFUNGIN ACETATE
Applicant:	Gland
Ingredient:	caspofungin acetate
Patents:	0

Pharmacology for NDA: 207092

Suppliers and Packaging for NDA: 207092

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	207092	ANDA	Sagent Pharmaceuticals	25021-194	25021-194-10	1 VIAL in 1 CARTON (25021-194-10) / 10 mL in 1 VIAL
CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	207092	ANDA	Sagent Pharmaceuticals	25021-195	25021-195-10	1 VIAL in 1 CARTON (25021-195-10) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	50MG/VIAL
Approval Date:	Sep 29, 2017	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	70MG/VIAL
Approval Date:	Sep 29, 2017	TE:	AP	RLD:	No

Complete Access Available with Subscription