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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213363
Company: JIANGSU HANSOH PHARM

Products on ANDA 213363

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213363

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/09/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213363

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	208366	APOTEX
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	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	211713	XELLIA PHARMS APS
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215241	ZYDUS PHARMS
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	208366	APOTEX
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	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	211713	XELLIA PHARMS APS
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215241	ZYDUS PHARMS
MYCAMINE	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	021506	ASTELLAS

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