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Search results for "JECFA" in comments (approximate match)
Status:
Possibly Marketed Outside US
Source:
NDA022276
(1988)
Source URL:
First approved in 1988
Source:
NDA022276
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
ANDA216232
(1987)
Source URL:
First approved in 1987
Source:
ANDA216232
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
Rejuvesol
Source URL:
First approved in 1987
Source:
21 CFR 349
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
CTI-01 (ethyl pyruvate) is an investigational anti-inflammatory agent for the treatment of critical inflammatory conditions. CTI-01 was developed by Critical Therapeutics as a stable prodrug of pyruvate, a potent antioxidant, and a free radical scavenger. The drug showed an anti-inflammatory and tissue protection activity in animal models of pancreatitis, ischemia-reperfusion injury, sepsis, renal injury, and endotoxemia. CTI-01 was investigated in phase 2 clinical trials on patients undergoing cardiac surgery with cardiopulmonary bypass, but despite positive results in animal models, administration of EP does not appear to confer any benefit to cardiac surgical patients undergoing cardiopulmonary bypass. Besides clinical applications, ethyl pyruvate is long used as an additive to pharmaceutical preparations and foods, including candy, beverages, and baked goods. It is generally recognized as safe by the FDA.
Status:
Possibly Marketed Outside US
Source:
ANDA088389
(1985)
Source URL:
First approved in 1985
Source:
ANDA088389
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Potassium bisulfite is a chemical compound with the chemical formula KHSO3. Potassium bisulphite is used for the preservation of colourless food materials such as fruit juices, squashes, apples and raw mango chutney. Potassium bisulfite solutions are used in a variety of different applications, including use as a food preservative (E228) to prevent spoilage and discoloration, as a preservative for pharmaceuticals (nebulizer solutions, parenterals, peritoneal dialysis solutions). It is also an antiseptic and sulfurous acid source, especially in brewing. Potassium bisulfite also functions as hair-waving/straightening agent. Potassium bisulfite is generally recognized as safe by FDA when used in accordance with good manufacturing or feeding practice, except that it is not used in meats or in food recognized as source of vitamin B1.
Status:
Possibly Marketed Outside US
Source:
PLIAGLIS by Atlas Powder
Source URL:
First approved in 1985
Source:
ANDA088450
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Sorbitan monopalmitate (Span 40) is a nonionic emulsifier, surfactant and food additive. The product of Croda Inc. Span 40 is used in skin care, hair care and decorative cosmetics. It is also used as an effector in compositions capable of facilitating penetration across a biological barrier. Inactive ingredient of some medications it improves transdermal delivery of drugs and is a potential carrier for topical drug delivery. In PLIAGLIS cream (lidocaine and tetracaine) sorbitan monopalmitate is used as an inactive ingredient. Sorbitan monopalmitate is a fatty acid sorbitan ester, yellowish brown wax, slightly soluble in isopropanol, xylene and liquid paraffin, insoluble in water, non-toxic.
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:
21 CFR 352
(2010)
Source URL:
First approved in 1984
Source:
ANDA209351
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
M016
(2024)
Source URL:
First approved in 1984
Source:
ANDA209351
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Status:
Possibly Marketed Outside US
Source:
ANDA210374
(1984)
Source URL:
First approved in 1984
Source:
ANDA210374
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 333C
(2014)
Source URL:
First approved in 1984
Source:
ANDA209351
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
ISOAMYL ACETATE is an organic compound that is the ester formed from isoamyl alcohol and acetic acid. It is present in many fruit aromas, especially banana, and is used in banana flavoring. It is a clear colorless liquid that is only slightly soluble in water, but very soluble in most organic solvents.