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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076513
Company: APOTEX INC

Products on ANDA 076513

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076513

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/14/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76513ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/13/2019	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
07/20/2020	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
08/06/2008	SUPPL-15	Labeling		Label is not available on this site.
02/26/2014	SUPPL-10	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076513

OFLOXACIN

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OCUFLOX	OFLOXACIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	019921	ALLERGAN
OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	202692	ALTAIRE PHARMS INC
OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	211524	AMNEAL
OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	076513	APOTEX INC
OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	076622	BAUSCH AND LOMB
OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	217904	CAPLIN
OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	078559	FDC LTD
OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	215886	MANKIND PHARMA
OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	076407	SENTISS

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