Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212080
Company: SENTISS

Products on ANDA 212080

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	0.5%	GEL;OPHTHALMIC	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212080

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/10/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212080Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/28/2025	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 212080

LOTEPREDNOL ETABONATE

GEL;OPHTHALMIC; 0.5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LOTEMAX	LOTEPREDNOL ETABONATE	0.5%	GEL;OPHTHALMIC	Prescription	Yes	AB	202872	BAUSCH AND LOMB INC
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	0.5%	GEL;OPHTHALMIC	Prescription	No	AB	212080	SENTISS
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	0.5%	GEL;OPHTHALMIC	Prescription	No	AB	215384	SUN PHARM