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Search results for "JECFA" in comments (approximate match)
Status:
Possibly Marketed Outside US
Source:
21 CFR 334
(2012)
Source URL:
First approved in 2002
Source:
NDA022410
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Acesulfame is a non-nutritive sweetener Acesulfame potassium is a calorie-free artificial sweetener, also known as Acesulfame K or Ace K (K being the symbol for potassium), and marketed under the trade names Sunett and Sweet One. In the European Union, it is known under the E number (additive code) E950. It was discovered accidentally in 1967 by German chemist Karl Clauss at Hoechst AG (now Nutrinova). In chemical structure, acesulfame potassium is the potassium salt of 6-methyl-1,2,3- oxathiazine-4(3H)-one 2,2-dioxide. Acesulfame K has been approved for a variety of uses in more than 90 countries. In 1998, the FDA broadened the US approval of acesulfame K to allow its use in nonalcoholic beverages. It is often blended with sucralose and used to decrease the bitter aftertaste of aspartame. A wide range of low-calorie foods and drinks contain acesulfame K, including table-top sweeteners, chewing gum, jam, dairy products, frozen desserts, drinks and baked goods. Acesulfame K is not broken down when digested, nor is it stored in the body. After being consumed, it is quickly absorbed by the body and then rapidly excreted, unchanged.
Status:
Possibly Marketed Outside US
Source:
ANDA208784
(1995)
Source URL:
First approved in 1995
Source:
ANDA208784
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 (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
NDA021591
(1995)
Source URL:
First approved in 1995
Source:
NDA021591
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Calcium Saccharin Anhydrous is an odorless, white crystalline powder sweetener. It is used as a sugar substitute in foods and beverages. It has been used in food for many years. In cosmetics and personal care products, it is used in the formulation of dental products, mouthwashes and lipstick.
Status:
Possibly Marketed Outside US
First approved in 1992
Source:
21 CFR 331
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Adipic acid has been incorporated into controlled-release formulation matrix tablets to obtain a pH-independent release for both weakly basic and weakly acidic drugs. It has also been incorporated into the polymeric coating of hydrophilic monolithic systems to modulate the intragel pH, resulting in zero-order release of hydrophilic drugs. The disintegration at intestinal pH of the enteric polymer shellac has been reported to improve when adipic acid was used as a pore-forming agent without affecting release in the acidic media. Adipic acid is used to make bisobrin an antifibrinolytic.
Status:
Possibly Marketed Outside US
First approved in 1990
Source:
21 CFR 358A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Palmitic acid is a saturated fatty acid, the principal constituent of refined palm oil, present in the diet and synthesized endogenously. Palmitic acid is able to activate the orphan G protein-coupled receptor GPR40. Palmitic acid was also a weak ligand of peroxisome proliferator-activated receptor gamma. Palmitic acid is a ligand of lipid chaperones - the fatty acid-binding proteins (FABPs). Dietary palm oil and palmitic acid may play a role in the development of obesity, type 2 diabetes mellitus, cardiovascular diseases and cancer.
Status:
Possibly Marketed Outside US
First approved in 1990
Source:
21 CFR 358A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Palmitic acid is a saturated fatty acid, the principal constituent of refined palm oil, present in the diet and synthesized endogenously. Palmitic acid is able to activate the orphan G protein-coupled receptor GPR40. Palmitic acid was also a weak ligand of peroxisome proliferator-activated receptor gamma. Palmitic acid is a ligand of lipid chaperones - the fatty acid-binding proteins (FABPs). Dietary palm oil and palmitic acid may play a role in the development of obesity, type 2 diabetes mellitus, cardiovascular diseases and cancer.
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2020)
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:
Provita Konquest by Provita Eurotech Ltd
(2012)
Source URL:
First approved in 1987
Source:
ANDA216232
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
ANDA088390
(1985)
Source URL:
First approved in 1985
Source:
ANDA088390
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.