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Search results for "PART 310 -- NEW DRUGS|Subpart E--Requirements for Specific New Drugs or Devices" in comments (approximate match)
Status:
US Previously Marketed
Source:
GLUTAVENE by TILDEN YATES
(1961)
Source URL:
First approved in 1939
Source:
FLANITHIN 325MG by TABLE ROCK
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Glutamic acid is a non-essential aminoacid used in biosynthesis of proteins. Besides being a building block of proteins, glutamic acid plays a principal role in neural activation. Glutamate is also responsible for the umami (savory) flavor of certain foods. In medicine, glutamate is used as a metabolic supplemnet in patients undergoing coronary surgery.
Status:
US Previously Marketed
Source:
Thorotrast by Heyden Chemical Corporation
(1931)
Source URL:
First marketed in 1931
Source:
Thorotrast by Heyden Chemical Corporation
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Thorium dioxide, a main component of Thorotrast that was used as a contrast agent for cerebral angiography. Thorotrast is an alpha emitter and primary site of deposition is the reticuloendothelial system including the liver, spleen, bone marrow, and lymph nodes. However was discovered, that this compound can cause hepatic angiosarcoma with a long latent period. That is why this contrast agent was withdrawn.
Status:
US Previously Marketed
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Thymol, a monoterpene, obtained from thyme oil or other volatile oils, is used as a stabilizer in pharmaceutic preparations. It has been used for its antiseptic, antibacterial, and antifungal actions to help reduce and prevent plaque and gingivitis. Recently was shown, that this substance was able to significantly reduce the oxidative stress associated with cataract. The results suggested that thymol might be a potential therapeutic approach in the prevention of diabetic complications through its aldose reductase enzyme inhibitory and antioxidant activities.
Status:
US Previously Marketed
Source:
Quinine Hypophosphite N.F.
(1921)
Source URL:
First marketed in 1921
Source:
Quinine Hypophosphite N.F.
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
QUININE HYPOPHOSPHITE, a salt of quinine, was formerly used, along with the hypophosphites of sodium, potassium, calcium, and iron, in the treatment of phthisis and neurasthenic conditions.
Status:
US Previously Marketed
Source:
Quinine and Urea Hydrochloride U.S.P.
(1921)
Source URL:
First marketed in 1921
Source:
Quinine and Urea Hydrochloride U.S.P.
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Quinine urea mixture is a long-acting local anesthetic and analgesic. However, the quinine-urea mixture could delay wound healing if directly injected into wound edges. A syringe with a long offset needle such as Moynihan’s for infiltrating “at a Distance from the Incision.” is recommended for quinine urea delivery.
Status:
US Previously Marketed
Source:
Quinine Salicylate U.S.P.
(1921)
Source URL:
First marketed in 1921
Source:
Quinine Salicylate U.S.P.
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Quinine soluble salts possess an extremely bitter taste, that may have a perplexing problem especially to children. That is why one of the most common combinations for oral administration is a slightly soluble quinine salicylate salt. It is known that now quinine is used in the absence of artemisin combination therapies (ARTs) to treat CQ resistant (CQR) P. falciparum malaria. Although the precise mechanism of the antimalarial activity of quinine is not completely understood, it can act via the inhibition on nucleic acid synthesis, on protein synthesis, and on glycolysis in Plasmodium falciparum, and also drug can affect via the binding with hemazoin in parasitized erythrocytes.
Status:
US Previously Marketed
Source:
Strychnine U.S.P.
(1921)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Strychnine is an indole alkaloid obtained from the seeds of the Indian tree Strychnos nux-vomica. It gets its scientific name “strychnos” from Carl Linnaeus, who classified it back in 1753, but it was known to the population of India way before then. Nux vomica originates in India. Strychnine-containing baits are currently labelled for below-ground use and are intended for the control of pocket gophers. Their use as indoor pesticides has been eliminated since 1989. In the past, strychnine has been used as a pesticide to control rats, moles, gophers, and coyotes. Strychnine is highly toxic to most domestic animals. Strychnine is a competitive antagonist at glycine receptors and thus a convulsant. It has been used as an analeptic, in the treatment of nonketotic hyperglycinemia and sleep apnea.
Status:
US Previously Marketed
Source:
STERILE UREA by HOSPIRA
(1976)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Pastaron (Urea) is a waste product of many living organisms, and is the major organic component of human urine. It is a very important starting material in a number of chemical syntheses, and is used on an industrial scale for the manufacture of fertilizers, pharmaceuticals, and resins. Urea is an osmotic diuretic similar to mannitol but more irritant. Applied topically, urea promotes hydration of keratin and mild keratolysis in dry skin. It increases water uptake by the stratum corneum and has an antipruritic effect. Pastaron is used to soften rough or dry skin caused by skin conditions such as eczema, psoriasis, keratosis, and others.
Status:
US Previously Marketed
Source:
Chloretone by Parke-Davis
(1911)
Source URL:
First marketed in 1911
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Chlorobutanol, or trichloro-2-methyl-2-propanol, is an analgesic and sedative hypnotic in man, and an experimental general anesthetic. It has antibacterial and antifungal properties. It is also used chemical preservative for parenteral drugs. It was found, that chlorobutanol inhibited mammalian Nav 1.2 channels at concentrations less than those used to preserve parenteral solutions. Its mechanism of inhibiting Na channels differs from that of local anesthetics in that it does not show use dependent or state dependent inhibition.
Status:
US Previously Marketed
First marketed in 1847
Class (Stereo):
CHEMICAL (ACHIRAL)
Chloroform is a colorless, sweet-smelling, dense liquid and widely used industrial and laboratory solvent. The total global flux of chloroform through the environment is approximately 660 000 tonnes per year, and about 90% of emissions are natural in origin. Many kinds of seaweed produce chloroform, and fungi are believed to produce chloroform in soil. Chloroform is used as an industrial solvent and as an intermediate in the manufacture of polymeric materials. The major use of chloroformtoday is in the production of the refrigerant R-22, commonly used in the air conditioning business. Inhaled chloroform anesthesia was introduced in 1847 and Chloroform subsequently became the most widely used volatile anaesthetic, and was used in horses before the end of the 19th century. Pure chloroform is known to be decomposed by the air with the formation of hydrochloric acid, phosgene and carbon dioxide. Phosgene is also generated metabolically from chloroform, and liver and kidney damage can ensue from its production.