Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217387
Company: GLAND

Products on ANDA 217387

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LATANOPROSTENE BUNOD	LATANOPROSTENE BUNOD	0.024%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217387

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217387Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 217387

LATANOPROSTENE BUNOD

SOLUTION/DROPS;OPHTHALMIC; 0.024%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LATANOPROSTENE BUNOD	LATANOPROSTENE BUNOD	0.024%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	217387	GLAND
VYZULTA	LATANOPROSTENE BUNOD	0.024%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AB	207795	BAUSCH AND LOMB