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Restrict the search for
angiotensin ii
to a specific field?
Status:
US Previously Marketed
Source:
LUTREPULSE KIT by FERRING
(1989)
Source URL:
First approved in 1978
Source:
NADA098379
Source URL:
Class:
MIXTURE
Targets:
Conditions:
Gonadorelin is a synthetic decapeptide prepared using solid phase peptide synthesis. GnRH is responsible for the release of follicle stimulating hormone and leutinizing hormone from the anterior pitutitary. In the pituitary GnRH stimulates synthesis and release of FSH and LH, a process that is controlled by the frequency and amplitude of GnRH pulses, as well as the feedback of androgens and estrogens. The pulsatility of GnRH secretion has been seen in all vertebrates, and it is necessary to ensure a correct reproductive function. Thus a single hormone, GnRH, controls a complex process of follicular growth, ovulation, and corpus luteum maintenance in the female, and spermatogenesis in the male. Its short half life requires infusion pumps for its clinical use. Gonadorelin is used for the treatment of amenorrhea, delayed puberty, and infertility the administration of gonadorelin is used to simulate the physiologic release of GnRH from the hypothalamus in treatment of delayed puberty, treatment of infertility caused by hypogonadotropic hypogonadism, and induction of ovulation in those women with hypothalamic amenorrhea. This results in increased levels of pituitary gonadotropins LH and FSH, which subsequently stimulate the gonads to produce reproductive steroids.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(v)(B) skin protectant:insect bites/stings 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:
SPOROSTACIN BENZALKONIUM CHLORIDE by ORTHO
(1961)
Source URL:
First marketed in 1921
Class:
MIXTURE
Benzalkonium chloride, also known as BZK, BKC, BAC, alkyldimethylbenzylammonium chloride and ADBAC, is a type of cationic surfactant. It is an organic salt called a quaternary ammonium compound. In 2011, a large clinical trial designed to evaluate the efficacy of hand sanitizers based on different active ingredients in preventing virus transmission amongst schoolchildren was re-designed to exclude sanitizers based on benzalkonium chloride due to safety concerns. Benzalkonium chloride has been in common use as a pharmaceutical preservative and antimicrobial since the 1940s. While early studies confirmed the corrosive and irritant properties of benzalkonium chloride, investigations into the adverse effects of, and disease states linked to, benzalkonium chloride have only surfaced during the past 30 years. Benzalkonium chloride is classed as a Category III antiseptic active ingredient by the United States Food and Drug Administration. Ingredients are categorised as Category III when "available data are insufficient to classify as safe and effective, and further testing is required”. Benzalkonium chloride is excluded from the current United States Food and Drug Administration review of the safety and effectiveness of consumer antiseptics and topical antimicrobial over-the-counter drug products, meaning it will remain a Category III ingredient. The mechanism of bactericidal/microbicidal action is thought to be due to disruption of intermolecular interactions. This can cause dissociation of cellular membrane lipid bilayers, which compromises cellular permeability controls and induces leakage of cellular contents. Other biomolecular complexes within the bacterial cell can also undergo dissociation. Enzymes, which finely control a wide range of respiratory and metabolic cellular activities, are particularly susceptible to deactivation. Critical intermolecular interactions and tertiary structures in such highly specific biochemical systems can be readily disrupted by cationic surfactants. Benzalkonium chloride is a human skin and severe eye irritant. It is a suspected respiratory toxicant, immunotoxicant, gastrointestinal toxicant and neurotoxicant.
Status:
US Previously Marketed
Source:
SPOROSTACIN BENZALKONIUM CHLORIDE by ORTHO
(1961)
Source URL:
First marketed in 1921
Class:
MIXTURE
Benzalkonium chloride, also known as BZK, BKC, BAC, alkyldimethylbenzylammonium chloride and ADBAC, is a type of cationic surfactant. It is an organic salt called a quaternary ammonium compound. In 2011, a large clinical trial designed to evaluate the efficacy of hand sanitizers based on different active ingredients in preventing virus transmission amongst schoolchildren was re-designed to exclude sanitizers based on benzalkonium chloride due to safety concerns. Benzalkonium chloride has been in common use as a pharmaceutical preservative and antimicrobial since the 1940s. While early studies confirmed the corrosive and irritant properties of benzalkonium chloride, investigations into the adverse effects of, and disease states linked to, benzalkonium chloride have only surfaced during the past 30 years. Benzalkonium chloride is classed as a Category III antiseptic active ingredient by the United States Food and Drug Administration. Ingredients are categorised as Category III when "available data are insufficient to classify as safe and effective, and further testing is required”. Benzalkonium chloride is excluded from the current United States Food and Drug Administration review of the safety and effectiveness of consumer antiseptics and topical antimicrobial over-the-counter drug products, meaning it will remain a Category III ingredient. The mechanism of bactericidal/microbicidal action is thought to be due to disruption of intermolecular interactions. This can cause dissociation of cellular membrane lipid bilayers, which compromises cellular permeability controls and induces leakage of cellular contents. Other biomolecular complexes within the bacterial cell can also undergo dissociation. Enzymes, which finely control a wide range of respiratory and metabolic cellular activities, are particularly susceptible to deactivation. Critical intermolecular interactions and tertiary structures in such highly specific biochemical systems can be readily disrupted by cationic surfactants. Benzalkonium chloride is a human skin and severe eye irritant. It is a suspected respiratory toxicant, immunotoxicant, gastrointestinal toxicant and neurotoxicant.
Status:
US Previously Marketed
First marketed in 1921
Class:
MIXTURE
Status:
US Previously Marketed
Source:
Sugar of Milk U.S.P.
(1921)
Source URL:
First marketed in 1921
Class:
MIXTURE
Targets:
Conditions:
Lactose is the most important carbohydrate in the milk of most species. Its biosynthesis takes place in the mammary gland. The molecular structures of α- and β -lactose differ in the orientation of a hydrogen- and a hydroxyl group on carbon atom no.1 in the glucose moiety. Both forms change into one another continuously. At room temperature, the equilibrium results in a ratio of about 40% α-lactose and 60% β-lactose. The fact that two forms of lactose exist which differ in molecular structure has profound effects on various properties of lactose such as crystallization behavior, crystal morphology, solid-state properties, and solubility. The intestine does not actively absorb lactose unless it is split into its two-monosaccharide components, i.e. glucose and galactose. This hydrolysis of lactose is affected by the enzyme lactase, which is produced by the epithelium cells in the brush-border of the small intestine. Thus, the capacity of mammals to digest lactose is dependent on the lactase activity in the intestine. The maximum activity of the enzyme occurs shortly after birth and declines during the weaning period, after which it remains at a relatively constant level. Genetically determined factors governing residual lactase activity also exist. Individuals having low lactase activity are called lactose malabsorbers. Lactose intolerance is a condition in which people have symptoms due to the decreased ability to digest lactose. The principal symptom of lactose intolerance is an adverse reaction to products containing lactose (primarily milk), including abdominal bloating and cramps, flatulence, diarrhea, nausea, borborygmi, and vomiting (particularly in adolescents). These appear one-half to two hours after consumption.
Status:
Possibly Marketed Outside US
Source:
Pain Relief Cream by ALLURE LABS INC.
Source URL:
First approved in 2000
Source:
Excel by United Pet Group
Source URL:
Class:
MIXTURE
Conditions:
Diazolidinylurea is a broad-spectrum antimicrobial preservative used in cosmetics and pharmaceutical preparations. It is especially active against gram-negative bacteria and is often combined with parabens. Diazolidinylurea is the most active member of the imidazolidinyl urea group, that acts as a formaldehyde releasers. Diazolidinylurea is used in many cosmetics, skin care products, shampoos, and conditioners, as well as a wide range of products including bubble baths, baby wipes, and household detergents.
Status:
Possibly Marketed Outside US
First approved in 1990
Source:
21 CFR 356
Source URL:
Class:
MIXTURE
Triphosphoric acid (also tripolyphosphoric acid), a condensed form of phosphoric acid. Sodium tripolyphosphate (STPP) is used as a preservative for poultry, meat, and seafood; it’s added to processed cheeses as an emulsifier and is used in food industry as an E number E451.
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.
Status:
Possibly Marketed Outside US
Source:
NDA019600
(1986)
Source URL:
First approved in 1986
Source:
NDA019600
Source URL:
Class:
MIXTURE
1,4-Sorbitan is a sorbitol anhydration product. 1,4-Sorbitan is a precursor to environmentally benign surfactants. It is a component of Sorbitol-Sorbitan mixtures used as soft gel plasticizers. They enhance the soft gelatin capsule finish gloss for a premium appearance, help to prevent leakage, provide consistent pharmaceutical quality, and extend shelf life by maintaining a proper moisture balance within the capsule shell.