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Search results for m root_codes_code in Code Literal (approximate match)
Status:
US Approved Rx
(1955)
Source:
NDA010040
(1955)
Source URL:
First approved in 1954
Source:
HYPAQUE by GE HEALTHCARE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
This compound belongs to the class of organic compounds known as aminobenzoic acids. These are benzoic acids containing an amine group attached to the benzene moiety. A commonly used x-ray contrast medium. Used, alone or in combination, for a wide variety of diagnostic imaging methods, including angiography, urography, cholangiography, computed tomography, hysterosalpingography, and retrograde pyelography. It can be used for imaging the gastrointestinal tract in patients allergic to barium. Radiopaque agents are drugs used to help diagnose certain medical problems. They contain iodine, which blocks x-rays. Depending on how the radiopaque agent is given, it localizes or builds up in certain areas of the body. The resulting high level of iodine allows the x-rays to make a "picture" of the area. The areas of the body in which the radiopaque agent localizes will appear white on the x-ray film. This creates the needed distinction, or contrast, between one organ and other tissues.
Status:
US Approved Rx
(2022)
Source:
NDA213953
(2022)
Source URL:
First marketed in 1937
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Testosterone is a steroid sex hormone found in both men and women. In men, testosterone is produced primarily by the Leydig (interstitial) cells of the testes when stimulated by luteinizing hormone (LH). It functions to stimulate spermatogenesis, promote physical and functional maturation of spermatozoa, maintain accessory organs of the male reproductive tract, support development of secondary sexual characteristics, stimulate growth and metabolism throughout the body and influence brain development by stimulating sexual behaviors and sexual drive. In women, testosterone is produced by the ovaries (25%), adrenals (25%) and via peripheral conversion from androstenedione (50%). Testerone in women functions to maintain libido and general wellbeing. Testosterone exerts a negative feedback mechanism on pituitary release of LH and follicle-stimulating hormone (FSH). Testosterone may be further converted to dihydrotestosterone or estradiol depending on the tissue. The effects of testosterone in humans and other vertebrates occur by way of two main mechanisms: by activation of the androgen receptor (directly or as DHT), and by conversion to estradiol and activation of certain estrogen receptors. Free testosterone (T) is transported into the cytoplasm of target tissue cells, where it can bind to the androgen receptor, or can be reduced to 5α-dihydrotestosterone (DHT) by the cytoplasmic enzyme 5α-reductase. DHT binds to the same androgen receptor even more strongly than T, so that its androgenic potency is about 2.5 times that of T. The T-receptor or DHT-receptor complex undergoes a structural change that allows it to move into the cell nucleus and bind directly to specific nucleotide sequences of the chromosomal DNA. The areas of binding are called hormone response elements (HREs), and influence transcriptional activity of certain genes, producing the androgen effects. Testosterone is used as hormone replacement or substitution of diminished or absent endogenous testosterone. Use in males: For management of congenital or acquired hypogonadism, hypogonadism associated with HIV infection, and male climacteric (andopause). Use in females: For palliative treatment of androgen-responsive, advanced, inoperable, metastatis (skeletal) carcinoma of the breast in women who are 1-5 years postmenopausal; testosterone esters may be used in combination with estrogens in the management of moderate to severe vasomotor symptoms associated with menopause in women who do not respond to adequately to estrogen therapy alone.
Status:
US Approved Rx
(1981)
Source:
NDA018469
(1981)
Source URL:
First marketed in 1921
Source:
Emulsion of Cod Liver Oil with Calcium Phosphate N.F.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Phosphate is a major intracellular anion in mammals. Hydrogen phopshate is a protonated form of phosphate. In serum, phosphate exists in two forms, dihydrogen phosphate (H2PO4) and its salt, mono-hydrogen phosphate (HPO4). At the physiologic pH of 7.40, the pK of H2PO4 is 6.8 and the ratio of HPO4 to H2PO4 is 4:1. Altered level of phosphate can be an indicator of various disorders, such as chronic renal failure, hypoparathyroidism, familial intermittent hyperphosphatemia, endocrine disorders, hyperthyroidism, acromegaly, juvenile hypogonadism, etc. These disorders may lead to either hyper- or hypophosphatemia, which can be caused by cellular shifts of phosphate. Patients with hypophosphatemia can be treated with dietary phosphate supplements (potassium phosphate, for example).
Status:
US Approved Rx
(2012)
Source:
NDA203922
(2012)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Nitrite Ion is a symmetric anion with equal N–O bond lengths. Nitrite is important in biochemistry as a source of the potent vasodilator nitric oxide. Nitrate or nitrite (ingested) under conditions that result in endogenous nitrosation has been classified as "Probably carcinogenic to humans" (Group 2A) by International Agency for Research on Cancer (IARC), the specialized cancer agency of the World Health Organization (WHO) of the United Nations. Sodium nitrite is used for the curing of meat because it prevents bacterial growth and, as it is a reducing agent (opposite of oxidation agent), in a reaction with the meat's myoglobin, gives the product a desirable pink-red "fresh" color, such as with corned beef. This use of nitrite goes back to the Middle Ages, and in the US has been formally used since 1925. Because of the relatively high toxicity of nitrite (the lethal dose in humans is about 22 milligrams per kilogram of body weight), the maximum allowed nitrite concentration in meat products is 200 ppm. At these levels, some 80 to 90% of the nitrite in the average U.S. diet is not from cured meat products, but from natural nitrite production from vegetable nitrate intake. Under certain conditions – especially during cooking – nitrites in meat can react with degradation products of amino acids, forming nitrosamines, which are known carcinogens. However, the role of nitrites (and to some extent nitrates) in preventing botulism by preventing C. botulinum endospores from germinating have prevented the complete removal of nitrites from cured meat, and indeed by definition in the U.S., meat cannot be labeled as "cured" without nitrite addition. They are considered irreplaceable in the prevention of botulinum poisoning from consumption of cured dry sausages by preventing spore germination. Nitrite is a member of the drug class antidotes and is used to treat Cyanide Poisoning.
Status:
US Approved Rx
(2012)
Source:
NDA203923
(2012)
Source URL:
First marketed in 1921
Source:
Sodium Thiosulphate U.S.P.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Sodium thiosulfate (sodium thiosulphate/STS) is a chemical and medication. As a medication, it is used in combination with sodium nitrite under the trade name to NITHIODOTE treat cyanide poisoning. The primary route of endogenous cyanide detoxification is by enzymatic transulfuration to thiocyanate (SCN- ), which is relatively nontoxic and readily excreted in the urine. Sodium thiosulfate is thought to serve as a sulfur donor in the reaction catalyzed by the enzyme rhodanese, thus enhancing the endogenous detoxification of cyanide. In addition, Sodium thiosulfate is used in calciphylaxis in hemodialysis patients with end-stage kidney disease. Calciphylaxis is vasculopathy characterized by ischemia and painful skin necrosis due to calcification and intimal fibroplasia of thrombosis of the panicular arterioles. Sodium thiosulfate is used as treatment due to its antioxidant activity and as a chelating. Sodium thiosulfate renders renal protection by modulating the mitochondrial KATP channel for preventing urolithiasis. Moreover, STS was assumed to play a vital role in on ischemia reperfusion injury (IR). The effectiveness of STS as a cardioprotective agent was attributed to the reduction of apoptosis by binding to the active site of caspase-3 in silico, which was substantiated by the reduced expression of caspase-3 and poly ADP ribose polymerase levels.
Status:
US Approved Rx
(2023)
Source:
ANDA215469
(2023)
Source URL:
First marketed in 1921
Source:
Potassium Sulphate N.F.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
SULFATE (as sodium sulfate, potassium sulfate, and magnesium sulfate) is a component of SUPREP Bowel Prep Kit. It is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. Sulfate salts provide sulfate anions, which are poorly absorbed. The osmotic effect of unabsorbed sulfate anions and the associated cations causes water to be retained within the gastrointestinal tract. SUPREP Bowel Prep Kit, when ingested with a large volume of water, produces copious watery diarrhea.
Status:
US Approved Rx
(1984)
Source:
ANDA088638
(1984)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Acetic acid (a component of vinagre) is used in medicine for the treatment of otitis externa caused by bacterial infections. The solution containing acetic acid was approved by FDA.
Status:
US Approved OTC
Source:
21 CFR 355.10(b)(1) anticaries:dentifrices sodium monolfuorophosphate (gel or paste)
Source URL:
First approved in 1953
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Monofluorophosphate (MFP) is an anion, which is a phosphate group with one oxygen atom substituted with a fluorine atom. Sodium Monofluorophosphate is intended to be used by both petitioners in food supplements as a source of fluoride in the forms of multi-vitamin, multi-mineral supplements, solid tablets or tablets dispersible in liquid. The toxic effects of Monofluorophosphate are attributable to the fluoride ion released by the in vivo hydrolysis of the parent compound. The Monofluorophosphate ion appears to play no role. The acute toxicity of Monofluorophosphate is somewhat less than that of NaF, due to the lesser availability of fluoride in the short term from Monofluorophosphate. In the long term, Monofluorophosphate produces virtually the same picture of renal effects and skeletal storage of fluoride as does NaF. Sodium Monofluorophosphate dissociates into sodium and Monofluorophosphate ions in the intestinal tract, the latter being absorbed mainly in the upper small intestine.
Status:
US Approved OTC
Source:
21 CFR 355.10(a)(2) anticaries:dentifrices sodium fluoride powder
Source URL:
First marketed in 1921
Source:
Calcium Chloride U.S.P.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Olaflur (amine fluoride 297, trade name elmex gel) is a fluoride-containing substance that is an ingredient of toothpastes and solutions for the prevention of dental caries. Especially in combination with dectaflur, it is also used in the form of gels for the treatment of early stages of caries, sensitive teeth, and by dentists for the refluoridation of damaged tooth enamel. Olaflur is a salt consisting of an alkyl ammonium cation and fluoride as the counterion. With a long lipophilic hydrocarbon chain, the cation has surfactant properties. It forms a film layer on the surface of teeth, which facilitates incorporation of fluoride into the enamel. The top layers of the enamel's primary mineral, hydroxylapatite, are converted into the more robust fluorapatite. The fluoridation reaches only a depth of a few nanometres, which has raised doubts whether the mechanism really relies on the formation of fluorapatite.
Status:
US Approved OTC
Source:
21 CFR 331.11(m) antacid:tartrate-containing tartrate (acid or salt)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Tartaric acid is found in many plants such as grapes, tamarinds, pineapples, mulberries and so on. Wine lees (called mud in the US), the sediment collected during the fermentation of grapes, contains potassium bitartrate (potassium hydrogen tartrate) as its major component. L-(+)-tartaric acid is an enantiomer of tartaric acid. Twenty five years before the tetrahedral structure for carbon was proposed in 1874 to explain the optical activity and other properties of organic compounds, Louis Pasteur discovered the existence of enantiomerism in tartaric acid. L-(+)-tartaric acid is widely used in food and beverage as acidity regulator with E number E334.