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 five NDAs. It is available from two suppliers. There is one patent protecting this drug. 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. Five 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
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020583

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 020583

Anti-Allergic Agents

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	24208-299-01	1 BOTTLE in 1 CARTON (24208-299-01) / 1 mL in 1 BOTTLE
LOTEMAX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020583	NDA	Bausch & Lomb Incorporated	24208-299	24208-299-05	1 BOTTLE in 1 CARTON (24208-299-05) / 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION/DROPS;OPHTHALMIC			Strength	0.5%
Approval Date:	Mar 9, 1998	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020583

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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	See Plans and Pricing	See Plans and Pricing
Bausch And Lomb	LOTEMAX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020583-001	Mar 9, 1998	See Plans and Pricing	See Plans and Pricing
Bausch And Lomb	LOTEMAX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020583-001	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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