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Search results for telotristat root_codes_comments in Code Comments (approximate match)
Status:
Possibly Marketed Outside US
First approved in 2010
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Ethyl linoleate (ELA) is an essential fatty acid used in many cosmetics for its anti-inflammatory properties. It inhibits the action of the reactive species of oxygen released by neutrophils due to an excess of bacteria, and prevents the hyperkeratinization induced by a lack of linoleic acid. Though there are few reports stating the antiinflammatory activity of ELA, the mechanism by which ELA exhibits anti-inflammatory activity remains unclear. An aqueous emulsion of ethyl linoleate can be used as parenteral injection for curring ailments where a high plasma-cholesterol level of the blood is indicated. Improvements in liver function tests during the administration of ELA were noticed in almost all cases with a few aggravated exceptions. The administration of ELA can expect the satisfactory response to the patients both with liver cirrhosis and with chronic hepatitis.
Status:
Possibly Marketed Outside US
Source:
ANDA040069
(1996)
Source URL:
First approved in 1996
Source:
ANDA040069
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Creatinine is a product of metabolism of creatine phosphate, a molecule that serves as a rapidly mobilizable reserve of a brain and skeletal muscle. Creatinine is excreted by kidneys with little or no reabsorption. Serum creatinine is the most commonly used indicator of renal function.
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.
Status:
Possibly Marketed Outside US
First approved in 1961
Source:
NDA012911
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Ethylparaben is produced naturally and found in several fruits and insects, where it acts as an antimicrobial agent. Ethylparaben is mainly used as antiseptics in cosmetics, food and medicine (E number E214). It is also can be used as feed preservatives and antiseptic for bacteria. Ethylparaben is readily absorbed from the gastrointestinal tract or through the skin. It is hydrolyzed to p-hydroxybenzoic acid and rapidly excreted in urine without accumulating in the body. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), cosmetic products and ingredients, other than color additives, do not need FDA approval before they go on the market. Broad concentration ranges reported in each product category in 1981 were < 0.1% and > 0.1% to 1%. Studies show the in vivo estrogenicity of MP and EP at human exposure levels, and indicate that populations exposed to large amounts of MP and EP may have a high burden of estrogenicity-related diseases.
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Noopept (DVD-111) is a peptide promoted and prescribed in Russia and neighbouring countries as a nootropic. Noopept was patented by Russian-based pharmaceutical company JSC LEKKO Pharmaceuticals in the 1996. Research shows Noopept has similar effects, but works differently than other nootropics in the racetam-family. The compound is patented in both the US and Russia with patent of Russian Federation number 2119496, U.S. Patent 5,439,930 issued 8/8/1995. Noopept exhibits a combined neuroprotector effect both in vitro and in vivo. Noopept decreases the extent of necrotic damage caused by photoinduced thrombosis of cortical blood vessels. It was established that the neuroprotector effect of noopept is related to its action upon the well-known "triad", whereby the drug reduces neurotoxic effects of excess extracellular calcium, glutamate, and free radicals. Two additional components of the neuroprotector action of noopept are related to the antiinflammatory and antithrombotic activity.
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (RACEMIC)
Ethyl loflazepate (Lof) has been used widely as a sedative and anxiolytic agent for nearly 20 years. Ethyl loflazepate was designed to be a prodrug for descarboxyloflazepate, its active metabolite. It is the active metabolite which is responsible for most of the pharmacological effects rather than ethyl loflazepate. The main metabolites of ethyl loflazepate are descarbethoxyloflazepate, loflazepate and 3-ydroxydescarbethoxyloflazepate which are the benzodiazepine receptor agonists. Ethyl loflazeplate is commercialized in Mexico, under the trade name Victan. It is officially approved for the following conditions Anxiety: Post-trauma anxiety; Anxiety associated with severe neuropathic pain; Generalized anxiety disorder (GAD); Panic attack; Delirium tremens. It possesses anxiolytic, anticonvulsant, sedative and skeletal muscle relaxant properties. Accumulation of the active metabolites of ethyl loflazepate are not affected by those with renal failure or impairment. The symptoms of an overdose of ethyl loflazepate include sleepiness, agitation and ataxia. Hypotonia may also occur in severe cases. These symptoms occur much more frequently and severely in children. High doses of the antidepressant fluvoxamine may potentiate the adverse effects of ethyl loflazepate.
Status:
US Previously Marketed
Source:
21 CFR 310.527(a) hair loss prevention polysorbate 60
Source URL:
First approved in 1938
Source:
Belladonna and Opium by Bryant Ranch Prepack
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
First approved in 1964
Source:
Stop-A-Leak by H. W. Naylor Company Inc.
Source URL:
Class:
MIXTURE
Status:
US Approved OTC
Source:
21 CFR 349.12(d)(4) ophthalmic:demulcents polysorbate 80
Source URL:
First approved in 1949
Class:
POLYMER
Conditions:
Polysorbate 80 is a nonionic surfactant and emulsifier often used in foods and cosmetics. Polysorbate 80 is an excipient that is used to stabilize aqueous formulations of medications for parenteral administration, and used as an emulsifier in the manufacture of the popular antiarrhythmic amiodarone. Polysorbate 80 is also used as an excipient in some European and Canadian influenza vaccines. Influenza vaccines contain 25 μg of polysorbate 80 per dose. Polysorbate 80 is also used in the culture of Mycobacterium tuberculosis in Middlebrook 7H9 broth. It is also used as an emulsifier in the estrogen-regulating drug Estrasorb. In Europe and America, people eat about 100 mg of polysorbate 80 in foods per day on average. Polysorbate 80 has not been found to be carcinogenic. Rats fed with diets containing up to 5% polysorbate 80 by volume for 12 weeks showed no toxic effects.
Status:
US Previously Marketed
Source:
21 CFR 310.527(a) hair loss prevention polysorbate 20
Source URL:
First approved in 1978
Source:
60-Second Fluoride Mint by Patterson Dental Supply Inc
Source URL:
Class:
POLYMER