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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 215550

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NDA 215550 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 six 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 215550

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

Medical Subject Heading (MeSH) Categories for 215550

Anti-Allergic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION/DROPS;OPHTHALMIC			Strength	0.2%
Approval Date:	Dec 26, 2023	TE:	AB	RLD:	No

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