Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206908
Company: GLAND

Products on ANDA 206908

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206908

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/20/2024	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206908

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; EQ 250MG/50ML (EQ 5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	200674	FRESENIUS KABI USA
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	206908	GLAND
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	091375	HIKMA FARMACEUTICA
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078579	HOSPIRA
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	090343	INFORLIFE

INJECTABLE;INJECTION; EQ 500MG/100ML (EQ 5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	200674	FRESENIUS KABI USA
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	206908	GLAND
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	091375	HIKMA FARMACEUTICA
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078579	HOSPIRA
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	090343	INFORLIFE

INJECTABLE;INJECTION; EQ 750MG/150ML (EQ 5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	200674	FRESENIUS KABI USA
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	206908	GLAND
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	091375	HIKMA FARMACEUTICA
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078579	HOSPIRA
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	090343	INFORLIFE