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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020583

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NDA 020583 describes LOTEMAX, which is a drug marketed by Bausch And Lomb Inc, Bausch And Lomb, and Pharmos, and is included in four 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. Two suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
Summary for 020583
Tradename:LOTEMAX
Applicant:Bausch And Lomb
Ingredient:loteprednol etabonate
Patents:0
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020583
Medical Subject Heading (MeSH) Categories for 020583
Suppliers and Packaging for NDA: 020583
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020583 NDA Bausch & Lomb Incorporated 24208-299 N 24208-299-05
LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020583 NDA Bausch & Lomb Incorporated 24208-299 N 24208-299-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Mar 9, 1998TE:RLD:Yes

Expired US Patents for NDA 020583

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020583-001 Mar 9, 1998 ➤ Sign Up ➤ Sign Up
Bausch And Lomb LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020583-001 Mar 9, 1998 ➤ Sign Up ➤ Sign Up
Bausch And Lomb LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020583-001 Mar 9, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
AstraZeneca
McKesson
Argus Health
Dow
Mallinckrodt
Express Scripts
Accenture
Colorcon

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