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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202442
Company: FDC LTD

Products on ANDA 202442

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LATANOPROST	LATANOPROST	0.005%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202442

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/22/2016	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/22/2023	SUPPL-11	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert		Label is not available on this site.
11/28/2022	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/19/2020	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/19/2020	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/19/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202442

LATANOPROST

SOLUTION/DROPS;OPHTHALMIC; 0.005%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LATANOPROST	LATANOPROST	0.005%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	200925	AMRING PHARMS
LATANOPROST	LATANOPROST	0.005%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	201006	BAUSCH AND LOMB
LATANOPROST	LATANOPROST	0.005%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	202077	CARNEGIE
LATANOPROST	LATANOPROST	0.005%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	202442	FDC LTD
LATANOPROST	LATANOPROST	0.005%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	091449	SANDOZ
LATANOPROST	LATANOPROST	0.005%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	201786	SOMERSET
XALATAN	LATANOPROST	0.005%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	020597	UPJOHN

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