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Abbreviated New Drug Application (ANDA): 207092
Company: GLAND
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
09/29/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207092Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/05/2019 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

09/05/2019 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 50MG/VIAL POWDER;INTRAVENOUS Prescription No AP 200833 HENGRUI PHARMA
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 50MG/VIAL POWDER;INTRAVENOUS Prescription No AP 211263 UBI
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
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 70MG/VIAL POWDER;INTRAVENOUS Prescription No AP 200833 HENGRUI PHARMA
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 70MG/VIAL POWDER;INTRAVENOUS Prescription No AP 211263 UBI
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 70MG/VIAL POWDER;INTRAVENOUS Prescription No AP 205923 XELLIA PHARMS APS
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