Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091644
Company: RISING

Products on ANDA 091644

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	Yes
LEVOFLOXACIN	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091644

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/20/2011	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/15/2020	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/15/2020	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/13/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
08/13/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
01/03/2012	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091644

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