Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Colorcon
Baxter
Cantor Fitzgerald
McKinsey
Daiichi Sankyo
Moodys
Chubb
QuintilesIMS

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200738

« Back to Dashboard

NDA 200738 describes LOTEMAX, which is a drug marketed by Bausch And Lomb Inc, Bausch And Lomb, and Pharmos, and is included in four NDAs. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the loteprednol etabonate profile page.
Summary for 200738
Tradename:LOTEMAX
Applicant:Bausch And Lomb
Ingredient:loteprednol etabonate
Patents:0
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 200738
Medical Subject Heading (MeSH) Categories for 200738
Suppliers and Packaging for NDA: 200738
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOTEMAX loteprednol etabonate OINTMENT;OPHTHALMIC 200738 NDA Bausch & Lomb Incorporated 24208-443 N 24208-443-35
LOTEMAX loteprednol etabonate OINTMENT;OPHTHALMIC 200738 NDA Bausch & Lomb Incorporated 24208-443 N 24208-443-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrength0.5%
Approval Date:Apr 15, 2011TE:RLD:Yes

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Cantor Fitzgerald
Baxter
McKinsey
Dow
Daiichi Sankyo
Cerilliant
UBS
Cipla

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.