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Search results for "Codex Alimentarius|Functional Classification|ANTIOXIDANT" in comments (approximate match)
Status:
Possibly Marketed Outside US
Source:
A-TEAM
Source URL:
First approved in 1984
Source:
NU-DERM SUNFADER Skin Lightener with Sunscreen (SPF 15) PABA FREE by OMP, INC.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Butylated hydroxytoluene, commonly known as BHT, is an organic compound that is used in the food, cosmetic, and pharmaceutical industry as an antioxidant. BHT is a substituted derivative of phenol. BHT helps to prevent the formation of free radicals and oxidation. When used in food products, it delays oxidative rancidity of fats and oils, and prevents loss of activity of oil-soluble vitamins. It may be found in pharmaceutical gels, creams and liquid or gelatin capsules, tablets and other pharmaceutical dosage forms. The ability of oral BHT to lead to cancer is a controversial topic, but most food industries have replaced it with butylated hydroxyanisole (BHA). BHT was first used as an antioxidant food additive in 1954. BHT does have other commercial uses, as in animal feeds and in the manufacture of synthetic rubber and plastics, where it also acts as an antioxidant. The U.S. Food and Drug Administration has deemed that BHT is safe enough when used in limited concentrations. It currently permits its use in concentrations of about 0.01% to 0.02% in most foods. As an emulsion stabilizer in shortening, it may be used in a somewhat higher concentration, 200 parts per million.
Status:
Possibly Marketed Outside US
Source:
Vedrop by Eastman Kodak
Source URL:
First approved in 1964
Source:
NADA012635
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Tocophersolan (Vedrop, tocofersolan) or d-alpha-Tocopheryl Polyethylene Glycol 1000 Succinate (TPGS) is a watersoluble derivative of the natural active (d-alpha) isomer of vitamin E. The active constituent of the medicinal product is essentially vitamin E (alpha tocopherol). Chronic congenital or hereditary cholestasis is a clinical condition where vitamin E deficiency results from an impaired bile secretion. Decreased intestinal absorption observed in chronic congenital or hereditary cholestatic patients is due to decreased bile secretion and the resulting decrease in intestinal cellular absorption. As a result, fatsoluble vitamins (i.e. vit. E) are not absorbed properly and deficiency can occur. Tocophersolan (Vedrop) is used to treat or prevent vitamin E deficiency (low vitamin E levels). It is used in children up to the age of 18 years who have congenital or hereditary chronic cholestasis and who cannot absorb vitamin E from the gut. Tocophersolan (Tocofersolan) can be absorbed from the gut in children who have difficulty absorbing fats and vitamin E from the diet. This can increase vitamin E levels in the blood and help to prevent neurological deterioration (problems in the nervous system) due to vitamin E deficiency. No treatment-related findings were reported, as all clinical observations and findings at autopsy were similar in treatment and control groups. In many of the studies, the LD50 was not
determined as tocofersolan was well tolerated.
Status:
Possibly Marketed Outside US
Source:
21 CFR 334
(2010)
Source URL:
First approved in 1964
Source:
21 CFR 358A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Propyl Gallate is the n-propyl ester of gallic acid (3,4,5-trihydroxybenzoic acid). It is soluble in ethanol, ethyl ether, oil, lard, and aqueous solutions of polyethylene glycol (PEG) ethers of cetyl alcohol, but only slightly soluble in water. Propyl Gallate currently is used as an antioxidant in a reported 167 cosmetic products at maximum concentrations of 0.1%. Propyl Gallate is a generally recognized as safe (GRAS) antioxidant to protect fats, oils, and fat-containing food from rancidity that results from the formation of peroxides. The biological activity of Propyl Gallate is consistent with its free-radical scavenging ability, with effects that include antimicrobial activity, enzyme inhibition, inhibition of biosynthetic processes, inhibition of the formation of nitrosamines, anesthesia, inhibition of neuromuscular response to chemicals, ionizing/ultraviolet (UV) radiation protection, chemoprotection, antimutagenesis, anticarcinogenesis and antitumorigenesis, antiteratogenesis, and anticariogenesis. Propyl gallate has being shown to be a hepatoprotector in vitro and in vivo.
Status:
Other
Class:
MIXTURE
Status:
US Previously Marketed
First marketed in 1921
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
ANDA076903
(2004)
Source URL:
First approved in 2004
Source:
ANDA076903
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
21 CFR 333C
(2003)
Source URL:
First approved in 1941
Source:
Morphine Sulfate by Bryant Ranch Prepack
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
First approved in 1995
Source:
21 CFR 341
Source URL:
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Source:
NCT01426750: Phase 4 Interventional Completed Malnutrition
(2002)
Source URL:
First approved in 1996
Source:
ANDA091226
Source URL:
Class:
STRUCTURALLY DIVERSE
Conditions:
Phopsholipon is a well-established lipoid brand characterizes natural and hydrogenated lecithin fractions and phospholipids from soybean, rapeseed (canola) or sunflower for pharmaceutical oral or topical applications and for use in cosmetics, as well in emulsions; liposomal formulations; as natural oil replenishing agents in shampoos and bath additives. Applications: preparation of mixed micelles, liposomes and micro emulsions. Solubilizer for parenteral administration forms; emulsifier for pharmacy, dermatology and cosmetics; phosphatidylcholine source for drugs and dietetics.
Status:
US Approved Rx
(2023)
Source:
ANDA216435
(2023)
Source URL:
First approved in 1953
Source:
CALCIUM DISODIUM VERSENATE by BAUSCH
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Edetic acid (EDTA) is a chelating agent. The U.S. Food and Drug Administration (FDA) approved edetic acid chelation therapy as a treatment for lead and heavy metal poisoning. Edetic acid in form of disodium salt was withdrawn from the market due to death resulting from hypocalcemia during chelation.