Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207344
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MICAFUNGIN SODIUM MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription AP No No
MICAFUNGIN SODIUM MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE;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
05/17/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207344Orig1s000ltr.pdf

MICAFUNGIN SODIUM

INJECTABLE;INTRAVENOUS; EQ 50MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MICAFUNGIN SODIUM MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 207344 FRESENIUS KABI USA
MYCAMINE MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription Yes AP 021506 ASTELLAS

INJECTABLE;INTRAVENOUS; EQ 100MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MICAFUNGIN SODIUM MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 207344 FRESENIUS KABI USA
MYCAMINE MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription Yes AP 021506 ASTELLAS

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