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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213542
Company: CAPLIN

Products on ANDA 213542

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213542

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/03/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213542

GATIFLOXACIN

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GATIFLOXACIN	GATIFLOXACIN	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	213542	CAPLIN
GATIFLOXACIN	GATIFLOXACIN	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	204227	SANDOZ
ZYMAXID	GATIFLOXACIN	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	022548	ABBVIE

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