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. Four 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

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 020803

Anti-Allergic Agents

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:	RX	Dosage:	SUSPENSION/DROPS;OPHTHALMIC			Strength	0.2%
Approval Date:	Mar 9, 1998	TE:		RLD:	Yes

Expired US Patents for NDA 020803

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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	See Plans and Pricing	See Plans and Pricing
Bausch And Lomb	ALREX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020803-001	Mar 9, 1998	See Plans and Pricing	See Plans and Pricing
Bausch And Lomb	ALREX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020803-001	Mar 9, 1998	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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