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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217903
Company: CAPLIN

Products on ANDA 217903

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 217903

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/05/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217903

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
OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS;OTIC	Prescription	No	AT	217903	CAPLIN
OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS;OTIC	Prescription	No	AT	216130	MANKIND PHARMA

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