Details for New Drug Application (NDA): 020583

✉ Email this page to a colleague

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 four suppliers. There are two patents 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. Eight 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

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

Subscribe to access the full database, or Sign Up
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.