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Last Updated: April 2, 2026

Details for New Drug Application (NDA): 216345

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NDA 216345 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 seven 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 216345

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

Pharmacology for NDA: 216345

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 216345

Anti-Allergic Agents

Suppliers and Packaging for NDA: 216345

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOTEPREDNOL ETABONATE	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	216345	ANDA	Amneal Pharmaceuticals NY LLC	60219-1366	60219-1366-3	1 BOTTLE in 1 CARTON (60219-1366-3) / 5 mL in 1 BOTTLE
LOTEPREDNOL ETABONATE	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	216345	ANDA	Amneal Pharmaceuticals NY LLC	60219-1367	60219-1367-6	1 BOTTLE in 1 CARTON (60219-1367-6) / 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION/DROPS;OPHTHALMIC			Strength	0.2%
Approval Date:	Dec 13, 2024	TE:	AB	RLD:	No

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