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Search results for m root_names_stdName in Standardized Name (approximate match)
Status:
US Approved Rx
(1987)
Source:
ANDA089175
(1987)
Source URL:
First marketed in 1929
Source:
Sandoptal by Sandoz
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Butalbital, 5-allyl-5-isobutylbarbituric acid, is a barbiturate with an intermediate duration of action. The different combinations with butalbital is approved. One of them is fioricet with codeine (butalbital, ccetaminophen, caffeine, and codeine phosphate) which is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of fioricet with codeine in the treatment of multiple recurrent headaches is unavailable. Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. This compound in general may appear in breast milk and readily cross the placental barrier. Monoamine oxidase (MAO) inhibitors may enhance the CNS effects. The mechanism of action for butalbital is proposed the following: this compound binds at a distinct binding site associated with a Cl- ionopore at the GABAA receptor, increasing the duration of time for which the Cl- ionopore is open. The post-synaptic inhibitory effect of GABA in the thalamus is, therefore, prolonged.
Status:
US Approved Rx
(2020)
Source:
NDA215007
(2020)
Source URL:
First marketed in 1925
Class (Stereo):
CHEMICAL (ACHIRAL)
Carbon dioxide is a colorless gas occurring naturally in Earth's atmosphere. Carbon dioxide is a primary carbon source for life on Earth. It is produced by all aerobic organisms during metabolism of carbohydrates and lipids. Carbon dioxide is used in food industry as an acidity regulator and for production of carbonated soft drinks and soda water. In medicine, carbon dioxide is commonly used as an insufflation gas for minimally invasive surgery (laparoscopy, endoscopy, and arthroscopy) to enlarge and stabilize body cavities to provide better visibility of the surgical area. A mixture of carbon dioxide and oxygen is used for stimulation of breathing after apnea, in anesthetic procedures to increase the depth of respiration, to facilitate blind intubations in anesthetic practice.
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
(1982)
Source:
NDA018664
(1982)
Source URL:
First marketed in 1921
Source:
Potassium Iodide U.S.P.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
US Approved Rx
(2003)
Source:
NDA021388
(2003)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Talcum powder is made from talc, a mineral made up mainly of the elements magnesium, silicon, and oxygen. As a powder, it absorbs moisture well and helps cut down on friction, making it useful for keeping skin dry and helping to prevent rashes. It is widely used in cosmetic products such as baby powder and adult body and facial powders, as well as in a number of other consumer products. The therapeutic action of talc instilled into the pleural cavity is believed to result from induction of an inflammatory reaction. This reaction promotes adherence of the visceral and parietal pleura, obliterating the pleural space and preventing reaccumulation of pleural fluid. Sterile Talc Powder, administered intrapleurally via chest tube, is indicated as a sclerosing agent to decrease the recurrence of malignant pleural effusions in symptomatic patients. The most often reported adverse experiences to intrapleurally-administered talc were fever and pain.
Status:
US Approved Rx
(1984)
Source:
NDA019011
(1984)
Source URL:
First marketed in 1921
Source:
Sodium Sulphate U.S.P.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Sodium sulfate anhydrous is an electrolyte replenisher and is used in isosmotic solutions so that administration does not disturb normal electrolyte balance and does not lead to absorption or excretion of water and ions. It is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults.
Status:
US Approved Rx
(2001)
Source:
NDA021146
(2001)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Atropine inhibits the muscarinic actions of acetylcholine on structures innervated by postganglionic cholinergic nerves, and on smooth muscles which respond to endogenous acetylcholine but are not so innervated. As with other antimuscarinic agents, the major action of atropine is a competitive or surmountable antagonism which can be overcome by increasing the concentration of acetylcholine at receptor sites of the effector organ (e.g., by using anticholinesterase agents which inhibit the enzymatic destruction of acetylcholine). The receptors antagonized by atropine are the peripheral structures that are stimulated or inhibited by muscarine (i.e., exocrine glands and smooth and cardiac muscle). Responses to postganglionic cholinergic nerve stimulation also may be inhibited by atropine but this occurs less readily than with responses to injected (exogenous) choline esters. Atropine is relatively selective for muscarinic receptors. Its potency at nicotinic receptors is much lower, and actions at non-muscarinic receptors are generally undetectable clinically. Atropine does not distinguish among the M1, M2, and M3 subgroups of muscarinic receptors.
Status:
US Approved Rx
(1971)
Source:
NDA016679
(1971)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Sodium lactate is primarily indicated as a source of bicarbonate for prevention or control of mild to moderate metabolic acidosis in patients
with restricted oral intake whose oxidative processes are not seriously impaired. Sodium Lactate is most commonly associated with an E number of “E325” Sodium Lactate blends are commonly used in meat and poultry products to extend shelf life and increase food safety. They have a broad antimicrobial action and are effective at inhibiting most spoilage and pathogenic bacteria. In addition sodium lactate is used in cosmetics as a humectant, providing moisture.
Status:
US Approved Rx
(2016)
Source:
ANDA207096
(2016)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Benzoic acid is a natural ingredient occurring in many foodstuffs and in plant extracts. Benzoic acid, its salts and esters are used as preservatives in cosmetic products, with a maximum concentration of 0.5 %. Benzoic acid and sodium benzoate are on the FDA list of substances that are generally recognized as safe (GRAS). Both may be used as antimicrobial agents, flavouring agents and as adjuvants with a current maximum level of 0.1% in food. Benzoic acid is a constituent of Whitfield Ointment, which is used for the treatment of fungal skin diseases such as tinea, ringworm, and athlete's foot. Adverse effect of Whitfield Ointment: occasionally, a localized mild inflammatory response occurs.
Status:
US Approved Rx
(2014)
Source:
NDA200656
(2014)
Source URL:
First marketed in 1921
Source:
Sodium Glycerophosphate U.S.P.
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Synthetic glycerophosphates have been known for many years and have been prepared in several ways. The acid may exist in two isomeric forms, alpha and beta. The L-a-acid is the naturally occurring form; the b-acid, present in hydrolyzates of lecithins from natural sources, arises from migration of the phosphoryl group from the a-carbon atom. Dehydrogenation of L-glycerol 3-phosphate produces Dihydroxyacetone phosphate and is part of the entry of glycerol (sourced from triglycerides) into the glycolytic pathway.