Last Updated: May 11, 2026

Details for New Drug Application (NDA): 215719

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NDA 215719 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 215719

Tradename:	LOTEPREDNOL ETABONATE
Applicant:	Lupin Ltd
Ingredient:	loteprednol etabonate
Patents:	0

Pharmacology for NDA: 215719

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 215719

Anti-Allergic Agents

Suppliers and Packaging for NDA: 215719

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOTEPREDNOL ETABONATE	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	215719	ANDA	Lupin Pharmaceuticals, Inc.	70748-300	70748-300-01	1 BOTTLE in 1 CARTON (70748-300-01) / 5 mL in 1 BOTTLE
LOTEPREDNOL ETABONATE	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	215719	ANDA	Lupin Pharmaceuticals, Inc.	70748-300	70748-300-02	1 BOTTLE in 1 CARTON (70748-300-02) / 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION/DROPS;OPHTHALMIC			Strength	0.5%
Approval Date:	Apr 24, 2024	TE:	AB	RLD:	No

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