Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205540
Company: GLAND PHARMA LTD

Products on ANDA 205540

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOFLOXACIN	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
LEVOFLOXACIN	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205540

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/22/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 205540

LEVOFLOXACIN

INJECTABLE;INJECTION; EQ 500MG/20ML (EQ 25MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOFLOXACIN	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	205540	GLAND PHARMA LTD
LEVOFLOXACIN	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	091644	RISING

INJECTABLE;INJECTION; EQ 750MG/30ML (EQ 25MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOFLOXACIN	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	205540	GLAND PHARMA LTD
LEVOFLOXACIN	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	091644	RISING