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Generated: June 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206110

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NDA 206110 describes CASPOFUNGIN ACETATE, which is a drug marketed by Cipla, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Labs Ltd, Sandoz Inc, and Xellia Pharms Aps, and is included in six NDAs. It is available from eight 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. Nine 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
Formulation / Manufacturing:see details
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:RXDosage:POWDER;INTRAVENOUSStrength50MG/VIAL
Approval Date:Dec 30, 2016TE:APRLD:No
Patent:➤ Try a Free TrialPatent Expiration:Dec 21, 2032Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength70MG/VIAL
Approval Date:Dec 30, 2016TE:APRLD:No
Patent:➤ Try a Free TrialPatent Expiration:Dec 21, 2032Product Flag?YSubstance Flag?Delist Request?

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