Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218087
Company: LUPIN LTD

Products on ANDA 218087

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	0.38%	GEL;OPHTHALMIC	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218087

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218087Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 218087

LOTEPREDNOL ETABONATE

GEL;OPHTHALMIC; 0.38%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LOTEMAX SM	LOTEPREDNOL ETABONATE	0.38%	GEL;OPHTHALMIC	Prescription	Yes	AB	208219	BAUSCH AND LOMB INC
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	0.38%	GEL;OPHTHALMIC	Prescription	No	AB	218087	LUPIN LTD