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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 212450


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NDA 212450 describes LOTEPREDNOL ETABONATE, which is a drug marketed by Sentiss, Slayback Pharma Llc, Sun Pharm, and Lupin Ltd, and is included in seven NDAs. It is available from two suppliers. Additional details are available on the LOTEPREDNOL ETABONATE profile page.

The generic ingredient in LOTEPREDNOL ETABONATE is loteprednol etabonate. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
Summary for 212450
Tradename:LOTEPREDNOL ETABONATE
Applicant:Sun Pharm
Ingredient:loteprednol etabonate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 212450
Medical Subject Heading (MeSH) Categories for 212450
Suppliers and Packaging for NDA: 212450
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOTEPREDNOL ETABONATE loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 212450 ANDA Sun Pharmaceutical Industries, Inc. 62756-232 62756-232-55 1 BOTTLE in 1 CARTON (62756-232-55) / 10 mL in 1 BOTTLE
LOTEPREDNOL ETABONATE loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 212450 ANDA Sun Pharmaceutical Industries, Inc. 62756-232 62756-232-56 1 BOTTLE in 1 CARTON (62756-232-56) / 15 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Feb 26, 2021TE:ABRLD:No

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