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Last Updated: July 2, 2020

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Details for New Drug Application (NDA): 208219

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NDA 208219 describes LOTEMAX SM, which is a drug marketed by Bausch And Lomb Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the LOTEMAX SM profile page.

The generic ingredient in LOTEMAX SM is loteprednol etabonate. There are ten 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 208219
Tradename:LOTEMAX SM
Applicant:Bausch And Lomb Inc
Ingredient:loteprednol etabonate
Formulation / Manufacturing:see details
Pharmacology for NDA: 208219
Medical Subject Heading (MeSH) Categories for 208219
Suppliers and Packaging for NDA: 208219
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOTEMAX SM loteprednol etabonate GEL;OPHTHALMIC 208219 NDA Bausch & Lomb Incorporated 24208-507 24208-507-01 1 BOTTLE in 1 CARTON (24208-507-01) > .5 g in 1 BOTTLE
LOTEMAX SM loteprednol etabonate GEL;OPHTHALMIC 208219 NDA Bausch & Lomb Incorporated 24208-507 24208-507-02 1 BOTTLE in 1 CARTON (24208-507-02) > 5 g in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;OPHTHALMICStrength0.38%
Approval Date:Feb 22, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 22, 2022
Regulatory Exclusivity Use:NEW STRENGTH
Patent:  Start TrialPatent Expiration:Dec 23, 2036Product Flag?YSubstance Flag?Delist Request?

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