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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207344
Company: FRESENIUS KABI USA

Products on ANDA 207344

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	Yes
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207344

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

Therapeutic Equivalents for ANDA 207344

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	220296	ASPIRO
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	216438	BIOCON PHARMA
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	207344	FRESENIUS KABI USA
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	213261	HIKMA
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	219712	HISUN PHARM HANGZHOU
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	213363	JIANGSU HANSOH PHARM
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215381	MEITHEAL
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	219273	QILU PHARM HAINAN
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	211713	XELLIA PHARMS APS
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	219518	YICHANG HUMANWELL
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215241	ZYDUS PHARMS

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	220296	ASPIRO
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	216438	BIOCON PHARMA
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	207344	FRESENIUS KABI USA
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	213261	HIKMA
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	219712	HISUN PHARM HANGZHOU
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	213363	JIANGSU HANSOH PHARM
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215381	MEITHEAL
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	219273	QILU PHARM HAINAN
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	211713	XELLIA PHARMS APS
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	219518	YICHANG HUMANWELL
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215241	ZYDUS PHARMS

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