Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205222
Company: LANNETT CO INC

Products on ANDA 205222

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOFLOXACIN	LEVOFLOXACIN	250MG/10ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205222

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/25/2018	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-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 205222

LEVOFLOXACIN

SOLUTION;ORAL; 250MG/10ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOFLOXACIN	LEVOFLOXACIN	250MG/10ML	SOLUTION;ORAL	Prescription	No	AA	205222	LANNETT CO INC
LEVOFLOXACIN	LEVOFLOXACIN	250MG/10ML	SOLUTION;ORAL	Prescription	No	AA	091678	NOVITIUM PHARMA