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FDA Approval

Caspofungin Acetate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Fosun Pharma USA Inc.
DUNS: 080920998
Effective Date
May 11, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Caspofungin(7 mg in 1 mL)

Products2

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 Code
72266-107
Application Number
ANDA207092
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
May 11, 2022
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 3.3 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Code: VUW370O5QEClass: ACTIBQuantity: 7 mg in 1 mL
SUCROSEInactive
Code: C151H8M554Class: IACTQuantity: 5 mg in 1 mL

Caspofungin Acetate

Product Details

NDC Product Code
72266-106
Application Number
ANDA207092
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
May 11, 2022
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 2.4 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACTQuantity: 3.6 mg in 1 mL
Code: VUW370O5QEClass: ACTIBQuantity: 5 mg in 1 mL
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Caspofungin Acetate - FDA Approval | MedPath