Last Updated: May 3, 2026

Details for New Drug Application (NDA): 213956

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NDA 213956 describes LOTEPREDNOL ETABONATE, which is a drug marketed by Hikma, Lupin Ltd, Sentiss, Sun Pharm, Amneal, Padagis Us, and Alembic, and is included in fourteen NDAs. It is available from eight suppliers. Additional details are available on the LOTEPREDNOL ETABONATE profile page.

The generic ingredient in LOTEPREDNOL ETABONATE is loteprednol etabonate; tobramycin. There are ten drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the loteprednol etabonate; tobramycin profile page.

Summary for 213956

Tradename:	LOTEPREDNOL ETABONATE
Applicant:	Hikma
Ingredient:	loteprednol etabonate
Patents:	0

Medical Subject Heading (MeSH) Categories for 213956

Anti-Allergic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL;OPHTHALMIC			Strength	0.5%
Approval Date:	Nov 29, 2023	TE:		RLD:	No

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