Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 091678
Company: NOVITIUM PHARMA

Products on ANDA 091678

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091678

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	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/23/2019	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/18/2018	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/22/2019	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/11/2015	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/08/2013	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/05/2011	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091678

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