Details for New Drug Application (NDA): 211263

NDA 211263 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 211263

Tradename:	CASPOFUNGIN ACETATE
Applicant:	Areva Pharms
Ingredient:	caspofungin acetate
Patents:	0

Pharmacology for NDA: 211263

Suppliers and Packaging for NDA: 211263

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	211263	ANDA	Areva Pharmaceuticals	59923-613	59923-613-70	1 VIAL, SINGLE-DOSE in 1 CARTON (59923-613-70) / 10.8 mL in 1 VIAL, SINGLE-DOSE
CASPOFUNGIN ACETATE	caspofungin acetate	POWDER;INTRAVENOUS	211263	ANDA	Areva Pharmaceuticals	59923-614	59923-614-50	1 VIAL, SINGLE-DOSE in 1 CARTON (59923-614-50) / 10.8 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	50MG/VIAL
Approval Date:	Oct 1, 2021	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	70MG/VIAL
Approval Date:	Oct 1, 2021	TE:	AP	RLD:	No

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