Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 206110
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 50MG/VIAL POWDER;INTRAVENOUS Prescription AP No No
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 70MG/VIAL POWDER;INTRAVENOUS Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/30/2016 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Review
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206110lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206110Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206110Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206110Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/28/2018 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206110s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206110Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/28/2018 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206110s001lbl.pdf
06/28/2018 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206110s001lbl.pdf
12/30/2016 ORIG-1 Approval Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206110lbl.pdf

CASPOFUNGIN ACETATE

POWDER;INTRAVENOUS; 50MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CANCIDAS CASPOFUNGIN ACETATE 50MG/VIAL POWDER;INTRAVENOUS Prescription Yes AP 021227 MERCK
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 50MG/VIAL POWDER;INTRAVENOUS Prescription No AP 206110 FRESENIUS KABI USA
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 50MG/VIAL POWDER;INTRAVENOUS Prescription No AP 207092 GLAND PHARMA LTD
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 50MG/VIAL POWDER;INTRAVENOUS Prescription No AP 207650 MYLAN LABS LTD
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 50MG/VIAL POWDER;INTRAVENOUS Prescription No AP 200833 SANDOZ INC
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 50MG/VIAL POWDER;INTRAVENOUS Prescription No AP 205923 XELLIA PHARMS APS

POWDER;INTRAVENOUS; 70MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CANCIDAS CASPOFUNGIN ACETATE 70MG/VIAL POWDER;INTRAVENOUS Prescription Yes AP 021227 MERCK
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 70MG/VIAL POWDER;INTRAVENOUS Prescription No AP 206110 FRESENIUS KABI USA
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 70MG/VIAL POWDER;INTRAVENOUS Prescription No AP 207092 GLAND PHARMA LTD
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 70MG/VIAL POWDER;INTRAVENOUS Prescription No AP 207650 MYLAN LABS LTD
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 70MG/VIAL POWDER;INTRAVENOUS Prescription No AP 200833 SANDOZ INC
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 70MG/VIAL POWDER;INTRAVENOUS Prescription No AP 205923 XELLIA PHARMS APS

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