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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Argus Health
Johnson and Johnson
Queensland Health

Generated: January 20, 2018

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 Inc, Bausch And Lomb, and Pharmos, 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 200738
Applicant:Bausch And Lomb
Ingredient:loteprednol etabonate
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 24208-443-35 1 TUBE in 1 CARTON (24208-443-35) > 3.5 g in 1 TUBE
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

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Argus Health
US Army

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