birch triterpenes - Generic Medications

Browse 2 brand name versions of birch triterpenes. Review brand names, dosage forms, strengths, and linked product records.

FILSUVEZ BIRCH TRITERPENES
CHIESI USA, INC. FDA Rx Only

FILSUVEZ (birch triterpenes) topical gel is a sterile botanical drug product for topical use and contains birch triterpenes in an oil base. FILSUVEZ is a colorless to slightly yellowish, opalescent, non-aqueous gel. Birch triterpenes is a botanical drug substance composed of a mixture of pentacyclic triterpenes. The botanical drug substance is a dry extract, refined, from birch bark from Betula pendula Roth , Betula pubescens Ehrh., as well as hybrids of both species, quantified to 72-88% (w/w) betulin, 2.4-5.7% (w/w) lupeol, 2.6-4.2% (w/w) betulinic acid, 0.5-1.2% (w/w) erythrodiol, 0.3-0.8% (w/w) oleanolic acid. The structural formulae of the main triterpene constituents are shown in Figure 1. Figure 1: Structure of Triterpene Constituents Betulin Erythrodiol Betulinic acid Oleanolic acid Lupeol Each gram of FILSUVEZ topical gel 10% (w/w) contains 100 mg of birch triterpenes in an oil base of refined sunflower oil. FILSUVEZ contains no additional excipients. Chemical Structure - Betulin Chemical Structure - Erythrodiol Chemical Structure - Betulinic acid Chemical Structure - Oleanolic acid Chemical Structure - Lupeol

FILSUVEZ BIRCH TRITERPENES
AMRYT PHARMACEUTICALS DAC FDA Rx Only

FILSUVEZ (birch triterpenes) topical gel is a sterile botanical drug product for topical use and contains birch triterpenes in an oil base. FILSUVEZ is a colorless to slightly yellowish, opalescent, non-aqueous gel. Birch triterpenes is a botanical drug substance composed of a mixture of pentacyclic triterpenes. The botanical drug substance is a dry extract, refined, from birch bark from Betula pendula Roth , Betula pubescens Ehrh., as well as hybrids of both species, quantified to 72-88% (w/w) betulin, 2.4-5.7% (w/w) lupeol, 2.6-4.2% (w/w) betulinic acid, 0.5-1.2% (w/w) erythrodiol, 0.3-0.8% (w/w) oleanolic acid. The structural formulae of the main triterpene constituents are shown in Figure 1. Figure 1: Structure of Triterpene Constituents Betulin Erythrodiol Betulinic acid Oleanolic acid Lupeol Each gram of FILSUVEZ topical gel 10% (w/w) contains 100 mg of birch triterpenes in an oil base of refined sunflower oil. FILSUVEZ contains no additional excipients. Chemical Structure - Betulin Chemical Structure - Erythrodiol Chemical Structure - Betulinic acid Chemical Structure - Oleanolic acid Chemical Structure - Lupeol

About birch triterpenes Generic Drugs

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