Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076527
Company: APOTEX INC

Products on ANDA 076527

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS;OTIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076527

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/2007	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076527.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/06/2008	SUPPL-7	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076527

OFLOXACIN

SOLUTION/DROPS;OTIC; 0.3%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS;OTIC	Prescription	No	AT	211525	AMNEAL
OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS;OTIC	Prescription	No	AT	076527	APOTEX INC
OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS;OTIC	Prescription	No	AT	076128	BAUSCH AND LOMB INC
OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS;OTIC	Prescription	No	AT	217903	CAPLIN
OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS;OTIC	Prescription	No	AT	215038	FDC LTD
OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS;OTIC	Prescription	No	AT	216130	MANKIND PHARMA
OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS;OTIC	Prescription	No	AT	216328	SOMERSET THERAPS LLC