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Generated: November 14, 2018

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Details for New Drug Application (NDA): 020803

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NDA 020803 describes ALREX, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from one supplier. Additional details are available on the ALREX profile page.

The generic ingredient in ALREX 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 020803
Tradename:ALREX
Applicant:Bausch And Lomb
Ingredient:loteprednol etabonate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020803
Medical Subject Heading (MeSH) Categories for 020803
Suppliers and Packaging for NDA: 020803
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALREX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020803 NDA Bausch & Lomb Incorporated 24208-353 24208-353-01 1 BOTTLE, DROPPER in 1 CARTON (24208-353-01) > 1 mL in 1 BOTTLE, DROPPER
ALREX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020803 NDA Bausch & Lomb Incorporated 24208-353 24208-353-05 1 BOTTLE, DROPPER in 1 CARTON (24208-353-05) > 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.2%
Approval Date:Mar 9, 1998TE:RLD:Yes

Expired US Patents for NDA 020803

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb ALREX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020803-001 Mar 9, 1998 ➤ Sign Up ➤ Sign Up
Bausch And Lomb ALREX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020803-001 Mar 9, 1998 ➤ Sign Up ➤ Sign Up
Bausch And Lomb ALREX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020803-001 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:

Cerilliant
Fish and Richardson
Queensland Health
McKinsey
Federal Trade Commission
Dow
Merck
Accenture
Medtronic

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