Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202872

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NDA 202872 describes LOTEMAX, which is a drug marketed by Bausch And Lomb Inc, Bausch And Lomb, and Pharmos, and is included in five NDAs. It is available from two suppliers. Additional details are available on the LOTEMAX profile page.

The generic ingredient in LOTEMAX is loteprednol etabonate. 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 profile page.
Summary for 202872
Tradename:LOTEMAX
Applicant:Bausch And Lomb Inc
Ingredient:loteprednol etabonate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202872
Medical Subject Heading (MeSH) Categories for 202872
Suppliers and Packaging for NDA: 202872
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOTEMAX loteprednol etabonate GEL;OPHTHALMIC 202872 NDA Bausch & Lomb Incorporated 24208-503 24208-503-07 1 BOTTLE in 1 CARTON (24208-503-07) > 5 g in 1 BOTTLE
LOTEMAX loteprednol etabonate GEL;OPHTHALMIC 202872 NDA Bausch & Lomb Incorporated 24208-503 24208-503-48 1 BOTTLE in 1 CARTON (24208-503-48) > .5 g in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;OPHTHALMICStrength0.5%
Approval Date:Sep 28, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 20, 2021
Regulatory Exclusivity Use:REVISED LABELING TO INCORPORATE THE PEDIATRIC USE OF LOTEPREDNOL ETABONATE GEL IN PATIENTS FOR THE TREATMENT OF POSTOPERATIVE INFLAMMATION FOLLOWING OCULAR SURGERY

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