Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
Johnson and Johnson
Mallinckrodt
Dow
Baxter

Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020583

See Plans and Pricing

« Back to Dashboard

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. 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. Four 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
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 24208-299-05 1 BOTTLE in 1 CARTON (24208-299-05) > 5 mL in 1 BOTTLE
LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020583 NDA Bausch & Lomb Incorporated 24208-299 24208-299-10 1 BOTTLE in 1 CARTON (24208-299-10) > 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Mar 9, 1998TE:ABRLD: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   Start Trial   Start Trial
Bausch And Lomb LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020583-001 Mar 9, 1998   Start Trial   Start Trial
Bausch And Lomb LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020583-001 Mar 9, 1998   Start Trial   Start Trial
>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

Serving leading biopharmaceutical companies globally:

Baxter
McKesson
AstraZeneca
Boehringer Ingelheim
Johnson and Johnson
Dow

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 verifification 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.