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Search results for telotristat root_codes_JECFA\ EVALUATION in JECFA EVALUATION (approximate match)
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2015)
Source URL:
First approved in 2012
Source:
505G(a)(3)
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
Cover Fx Mattifying Prime And Set
Source URL:
First approved in 2010
Source:
21 CFR 348
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Ethyl oleate is a fatty acid ester used as a solvent for pharmaceutical drug preparations involving lipophilic substances such as steroids. In vivo studies have demonstrated that Ethyl oleate and other fatty acid esters are also rapidly hydrolyzed to ethanol and free fatty acid. Ethyl oleate is one of the fatty acid ethyl esters (FAEE) that is formed in the body after ingestion of ethanol. There is a growing body of research literature that implicates FAEEs such as ethyl oleate as the toxic mediators of ethanol in the body (pancreas, liver, heart, and brain). Among the speculations is that ethyl oleate may be the toxic mediator of alcohol in fetal alcohol syndrome. The oral ingestion of ethyl oleate has been carefully studied and due to rapid degradation in the digestive tract, it appears safe for oral ingestion. Ethyl oleate is not currently approved by the U.S. Food and Drug Administration for any injectable use. However, it is used by compounding pharmacies as a vehicle for intramuscular drug delivery, in some cases to prepare the daily doses of progesterone in support of pregnancy. Studies which document the safe use of ethyl oleate in pregnancy for both the mother and the fetus have never been performed.
Status:
Possibly Marketed Outside US
Source:
NDA020062
(2001)
Source URL:
First approved in 1997
Source:
ANDA206724
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
ANDA078730
(1995)
Source URL:
First approved in 1995
Source:
ANDA078730
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
ANDA208784
(1995)
Source URL:
First approved in 1995
Source:
ANDA208784
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Status:
Possibly Marketed Outside US
Source:
M020
(2024)
Source URL:
First approved in 1995
Source:
ANDA078730
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Ethyl butyrate (C6H12O2) also known as ethyl butanoate, or butyric ether is an ester. Ethyl butyrate is used as an extract, as a flavoring or perfume, and as a solvent. It is a colorless liquid with a banana, orange or pineapple odor, and it is flammable. Exposure to ethyl butyrate can irritate the skin, eye, nose and throat. Applications include: artificial flavoring resembling orange juice or pineapple in alcoholic beverages, as a solvent in perfumes, and as a plasticizer for cellulose.
Status:
Possibly Marketed Outside US
Source:
M003
(2022)
Source URL:
First approved in 1985
Source:
NDA207768
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Ethyl maltol, a key food additive, and flavor enhancer is safe and is the most common sweet-associated component in electronic cigarette liquids. Ethyl maltol binds to human serum albumin (HSA) by situating within subdomain IIA (site I) of HSA.
Status:
Possibly Marketed Outside US
Source:
NDA021306
(1981)
Source URL:
First approved in 1981
Source:
NDA021306
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
BioSebMousse by VetBiotek, Inc.
(2016)
Source URL:
First approved in 1968
Source:
NDA204017
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Status:
Possibly Marketed Outside US
First approved in 1964
Source:
Stop-A-Leak by H. W. Naylor Company Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Ethyl acetate is a widely used synthetic solvent. It is used in cosmetics and considered to be safe. Ethyl acetate is cited as a direct and indirect food additive as detailed in the Code of Federal Regulations. Ethyl acetate is generally recognized as safe (GRAS) for use as a synthetic flavor and/or adjuvant; limitations on concentrations of use were not specified. Ethyl acetate was tested for in vitro in human breast cancer cell line and demonstrated considerable cytotoxicity.
