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Last Updated: January 29, 2026

Details for New Drug Application (NDA): 217597


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NDA 217597 describes LOTEPREDNOL ETABONATE AND TOBRAMYCIN, which is a drug marketed by Alembic and is included in one NDA. It is available from two suppliers. Additional details are available on the LOTEPREDNOL ETABONATE AND TOBRAMYCIN profile page.

The generic ingredient in LOTEPREDNOL ETABONATE AND TOBRAMYCIN 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 217597
Tradename:LOTEPREDNOL ETABONATE AND TOBRAMYCIN
Applicant:Alembic
Ingredient:loteprednol etabonate; tobramycin
Patents:0
Pharmacology for NDA: 217597
Mechanism of ActionCorticosteroid Hormone Receptor Agonists
Suppliers and Packaging for NDA: 217597
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOTEPREDNOL ETABONATE AND TOBRAMYCIN loteprednol etabonate; tobramycin SUSPENSION/DROPS;OPHTHALMIC 217597 ANDA Alembic Pharmaceuticals Limited 46708-801 46708-801-05 1 BOTTLE in 1 CARTON (46708-801-05) / 5 mL in 1 BOTTLE
LOTEPREDNOL ETABONATE AND TOBRAMYCIN loteprednol etabonate; tobramycin SUSPENSION/DROPS;OPHTHALMIC 217597 ANDA Alembic Pharmaceuticals Limited 46708-801 46708-801-10 1 BOTTLE in 1 CARTON (46708-801-10) / 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.5%;0.3%
Approval Date:Dec 10, 2025TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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