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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 200833


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NDA 200833 describes CASPOFUNGIN ACETATE, which is a drug marketed by Cipla, Fresenius Kabi Usa, Gland, Hengrui Pharma, Mylan Labs Ltd, UBI, and Xellia Pharms Aps, and is included in seven 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 200833
Tradename:CASPOFUNGIN ACETATE
Applicant:Hengrui Pharma
Ingredient:caspofungin acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200833
Suppliers and Packaging for NDA: 200833
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CASPOFUNGIN ACETATE caspofungin acetate POWDER;INTRAVENOUS 200833 ANDA Sandoz Inc 0781-3421 0781-3421-94 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3421-94) / 10.8 mL in 1 VIAL, SINGLE-DOSE (0781-3421-01)
CASPOFUNGIN ACETATE caspofungin acetate POWDER;INTRAVENOUS 200833 ANDA Sandoz Inc 0781-3423 0781-3423-94 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3423-94) / 10.8 mL in 1 VIAL, SINGLE-DOSE (0781-3423-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength50MG/VIAL
Approval Date:Jun 28, 2018TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength70MG/VIAL
Approval Date:Jun 28, 2018TE:APRLD:No

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