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Generated: June 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200738

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NDA 200738 describes LOTEMAX, which is a drug marketed by Bausch And Lomb, Pharmos, and Bausch And Lomb Inc, and is included in four 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 nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.

Summary for NDA: 200738

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 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 24208-443-01 1 TUBE in 1 CARTON (24208-443-01) > 1 g in 1 TUBE
LOTEMAX
loteprednol etabonate
OINTMENT;OPHTHALMIC 200738 NDA Bausch & Lomb Incorporated 24208-443 24208-443-35 1 TUBE in 1 CARTON (24208-443-35) > 3.5 g in 1 TUBE

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

Teva
Accenture
Fish and Richardson
Merck
Chinese Patent Office
Julphar
Covington
AstraZeneca
Baxter
Healthtrust

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.

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