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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077700
Company: RISING

Products on ANDA 077700

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOFLOXACIN	LEVOFLOXACIN	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077700

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2010	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 077700

LEVOFLOXACIN

SOLUTION/DROPS;OPHTHALMIC; 0.5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOFLOXACIN	LEVOFLOXACIN	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	077700	RISING
LEVOFLOXACIN	LEVOFLOXACIN	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	078282	RUBICON RESEARCH

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