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Search results for m root_names_stdName in Standardized Name (approximate match)
Status:
US Previously Marketed
Source:
VELOSEF by APOTHECON
(1977)
Source URL:
First approved in 1974
Source:
ANSPOR by GLAXOSMITHKLINE
Source URL:
Class:
MIXTURE
Conditions:
Cephradine is a semisynthetic cephalosporin antibiotic. Cephradine is active against the following organisms in vitro: Group A beta-hemolytic streptococci; Staphylococci, including coagulase-positive, coagulase-negative, and penicillinase-producing strains; Streptococcus pneumoniae (formerly Diplococcus pneumoniae); Escherichia coli; Proteus mirabilis; Klebsiella species; Hemophilus influenza. It works by stopping the growth of bacteria. It is used to treat a wide variety of bacterial infections (e.g., skin, ear, respiratory and urinary tract infections). Pseudomembranous colitis has been reported in patients receiving cephradine both orally and intravenously. Diarrhea generally starts 1 to 16 days after starting cephradine therapy. Gastrointestinal side effects have included nausea, vomiting. Hypersensitivity reactions have included rash, urticaria, pruritus, and joint pain. Bacteriostats may interfere with the bactericidal action of cephalosporins in acute infection; other agents, e.g., aminoglycosides, colistin, polymyxins, vancomycin, may increase the possibility of nephrotoxicity.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(i)(B) skin protectant:w/ sales less than $25,000 glyceryl stearate
Source URL:
First approved in 1971
Source:
ANDA090256
Source URL:
Class:
MIXTURE
Conditions:
Glyceryl 1-stearate (Glycerol monostearate), commonly known as GMS, is an organic molecule used as an emulsifier. GMS is a white, odorless, and sweet-tasting flaky powder that is hygroscopic. It is a glycerol ester of stearicacid. It occurs naturally in the body as a product of the breakdown of fats by pancreatic lipase, and is also found in fatty foods. GMS is a food additive used as a thickening, emulsifying, anti-caking, and preservative agent; an emulsifying agent for oils, waxes, and solvents; a protective coating for hygroscopic powders; a solidifier and control release agent in pharmaceuticals; and a resin lubricant. It is also used in cosmetics and hair care products. Used in antiperspirants and deodorants, baby care, body care, facial care, sun care, conditioners, facial make-up, creams and lotions-skin care, sprayable emulsions, feet, hands and nails, self-tanning, nail grooming and color cosmetics. GMS is largely used in baking preparations to add "body" to the food. It is responsible for giving ice cream and whipped cream its smooth texture. It is sometimes used as an anti-staling agent in bread. Glycerol 1-stearate is affirmed by FDA as GRAS.
Status:
US Previously Marketed
Source:
CAPREOMYCIN SULFATE by MYLAN LABS LTD
(2017)
Source URL:
First approved in 1971
Source:
CAPASTAT SULFATE by EPIC PHARMA LLC
Source URL:
Class:
MIXTURE
Targets:
Conditions:
Capreomycin is an antibiotic, which is used in combination other antituberculosis drugs fro the treatment of pulmonary infections caused by capreomycin-susceptible strains of M. tuberculosis when the primary agents (isoniazid, rifampin, ethambutol, aminosalicylic acid, and streptomycin) have been ineffective or cannot be used because of toxicity or the presence of resistant tubercle bacilli. Little is known about capreomycin's exact mechanism of action, but it is thought to inhibit protein synthesis by binding to the 70S ribosomal unit. Capreomycin also binds to components in the bacterial cell which result in the production of abnormal proteins.
Status:
US Previously Marketed
Source:
Guaiacol Sulfonate N.F.
(1937)
Source URL:
First marketed in 1937
Source:
Guaiacol Sulfonate N.F.
Source URL:
Class:
MIXTURE
Status:
US Previously Marketed
Source:
Solution of Potassium Arsenite U.S.P.
(1921)
Source URL:
First marketed in 1921
Source:
Solution of Potassium Arsenite U.S.P.
Source URL:
Class:
MIXTURE
Arsenite ion is a form of inorganic trivalent arsenic. It is derived from arsenous acid and known mainly for forming the basis of Fowler's solution (1% potassium arsenite (KAsO2). Fowler's solution has had a fascinating history in medicine during the past 200 years. The use of Fowler's solution was first described and published as a treatment for malaria and syphilis in the late 1700s. Many clinical applications for Fowler's solutions have been studied and utilized over the years, but toxicities have limited its utility. Even so, arsenic trioxide, chemically related to Fowler's solution, was approved by the US Food and Drug Administration for treating acute promyelocytic leukemia. The chronic arsenic exposure is a cause of immense health distress as it accounts for the increased risk of various disorders such as cardiovascular abnormalities, diabetes mellitus, neurotoxicity, and nephrotoxicity. In addition, the exposure to arsenic has been suggested to affect the liver function and to induce hepatotoxicity. Moreover, few studies demonstrated the induction of carcinogenicity especially cancer of the skin, bladder, and lungs after the chronic exposure to arsenic.
Status:
Possibly Marketed Outside US
Source:
Foaming Hand by Zhejiang Meimi Technology Co., Ltd.
(2022)
Source URL:
First approved in 2022
Source:
21 CFR 350
Source URL:
Class:
MIXTURE
Targets:
Conditions:
Aconitic Acid found in leaves and tubers of Aconitum napellus L., Ranunculaceae, in various species of Achillea (Compositae) and Equisetum (Equisetaceae), in beet root, and in sugar cane. It is indicated for the temporary relief of symptoms of chronic illness including fatigue, effects of toxin buildup, slowed metabolism, weakened constitution. The limited data on trans-aconitic acid indicate it to be less toxic than citric acid. Trans-aconitate salts appear to be excreted readily by the kidneys. There is no direct evidence that trans-aconitic acid is utilized as is the cis-aconitic acid isomer in mammalian metabolism although non-specific oxidation probably occurs.
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2007)
Source URL:
First approved in 2007
Source:
21 CFR 352
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
Sumaxin Cleansing Pads by Medimetriks Pharmaceuticals, Inc.
(2009)
Source URL:
First approved in 2007
Source:
21 CFR 333A
Source URL:
Class:
MIXTURE
Status:
First approved in 1998
Source:
21 CFR 334
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2015)
Source URL:
First approved in 1989
Source:
ANDA205563
Source URL:
Class:
MIXTURE
Monoglyceride citrate is a food additive that used as solubilizer and synergist for flavors and antioxidants. Monoglyceride citrate is effective to stabilize food such as margarine or mayonnaise, coffee creamers, and peanut butter.