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CASPOFUNGIN ACETATE

These highlights do not include all the information needed to use CASPOFUNGIN ACETATE FOR INJECTION safely and effectively. See full prescribing information for CASPOFUNGIN ACETATE FOR INJECTION. CASPOFUNGIN ACETATE for injection, for intravenous use Initial U.S. Approval: 2001

Approved
Approval ID

2239b366-663a-43d9-9cc6-d4bacb058abc

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 12, 2021

Manufacturers
FDA

UBI Pharma Inc.

DUNS: 658871159

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

CASPOFUNGIN ACETATE

PRODUCT DETAILS

NDC Product Code72843-434
Application NumberANDA211263
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateOctober 12, 2021
Generic NameCASPOFUNGIN ACETATE

INGREDIENTS (5)

ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
MANNITOLInactive
Quantity: 2.4 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SUCROSEInactive
Quantity: 3.6 mg in 1 mL
Code: C151H8M554
Classification: IACT
CASPOFUNGIN ACETATEActive
Quantity: 5 mg in 1 mL
Code: VUW370O5QE
Classification: ACTIB

CASPOFUNGIN ACETATE

PRODUCT DETAILS

NDC Product Code72843-533
Application NumberANDA211263
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateOctober 12, 2021
Generic NameCASPOFUNGIN ACETATE

INGREDIENTS (5)

MANNITOLInactive
Quantity: 3.3 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SUCROSEInactive
Quantity: 5 mg in 1 mL
Code: C151H8M554
Classification: IACT
CASPOFUNGIN ACETATEActive
Quantity: 7 mg in 1 mL
Code: VUW370O5QE
Classification: ACTIB
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CASPOFUNGIN ACETATE - FDA Approval | MedPath