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Status:
Possibly Marketed Outside US
Source:
Equestrolin
Source URL:
First approved in 1987
Source:
ANDA211721
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Luprostiol is a synthetic prostaglandin F2α and is a luteolytic agent. It is used for estrus control and termination of pregnancy in mares. In cattle Luprostiol is indicated for:
- Oestrus regulation / oestrus synchronization;
- Treatment of suboestrus;
- Induction of abortion;
- Induction of parturition;
- Treatment of pyometra, chronic endometritis and fetal mummification.
Status:
Possibly Marketed Outside US
First approved in 1987
Source:
NDA018963
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Mebrofenin is a chelating component which, when attached to Technetium TC-99M, forms a diagnostic drug marketed under the name Choletec. Choletec is approved by FDA as a hepatobiliary imaging agent.
Status:
Possibly Marketed Outside US
Source:
Rejuvesol
Source URL:
First approved in 1987
Source:
21 CFR 349
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
CTI-01 (ethyl pyruvate) is an investigational anti-inflammatory agent for the treatment of critical inflammatory conditions. CTI-01 was developed by Critical Therapeutics as a stable prodrug of pyruvate, a potent antioxidant, and a free radical scavenger. The drug showed an anti-inflammatory and tissue protection activity in animal models of pancreatitis, ischemia-reperfusion injury, sepsis, renal injury, and endotoxemia. CTI-01 was investigated in phase 2 clinical trials on patients undergoing cardiac surgery with cardiopulmonary bypass, but despite positive results in animal models, administration of EP does not appear to confer any benefit to cardiac surgical patients undergoing cardiopulmonary bypass. Besides clinical applications, ethyl pyruvate is long used as an additive to pharmaceutical preparations and foods, including candy, beverages, and baked goods. It is generally recognized as safe by the FDA.
Status:
Possibly Marketed Outside US
Source:
PLIAGLIS by Atlas Powder
Source URL:
First approved in 1985
Source:
ANDA088450
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Sorbitan monopalmitate (Span 40) is a nonionic emulsifier, surfactant and food additive. The product of Croda Inc. Span 40 is used in skin care, hair care and decorative cosmetics. It is also used as an effector in compositions capable of facilitating penetration across a biological barrier. Inactive ingredient of some medications it improves transdermal delivery of drugs and is a potential carrier for topical drug delivery. In PLIAGLIS cream (lidocaine and tetracaine) sorbitan monopalmitate is used as an inactive ingredient. Sorbitan monopalmitate is a fatty acid sorbitan ester, yellowish brown wax, slightly soluble in isopropanol, xylene and liquid paraffin, insoluble in water, non-toxic.
Status:
Possibly Marketed Outside US
Source:
TrophAmine
Source URL:
First approved in 1984
Source:
NDA019018
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
N-Acetyltyrosine is an acetylated derivative of the amino acid L-tyrosine. Ordinary L-tyrosine is less stable and also less soluble in water, which may result in reduced bioavailability. Acetylation enhances the solubility and stability of certain amino acids. N-Acetyltyrosine is commonly used in place of tyrosine in parenteral nutrition. It converts to tyrosine and then can be used in neurotransmitter treatment as a precursor of cathecholamine. N-Acetyltyrosine supports brain function by supporting the synthesis of the catecholamines norepinephrine and dopamine (neurotransmitters). N-Acetyltyrosine supplements are used to improve memory and cognitive performance in humans while they are experiencing psychological stress.
Status:
Possibly Marketed Outside US
First approved in 1984
Source:
NU-DERM SUNFADER Skin Lightener with Sunscreen (SPF 15) PABA FREE by OMP, INC.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Parabens are widely used preservatives in basic necessities such as cosmetic and pharmaceutical products. It was found, that butylparaben has estrogenic and antiandrogenic properties and is known to reduce sperm counts in rats following perinatal exposure. In addition was observed, that butylparaben exerted endocrine disrupting effects on both male and female offspring. In 2009-2010, 80 pregnant women from Ottawa Canada participated in the Plastics and Personal-Care Product Use in Pregnancy (P4) Study. Women kept a diary of products that they used 24 h prior to and during the collection. All parabens measured in maternal urine had moderate to high reproducibility. Women who used lotions in the past 24 h had significantly higher geometric mean paraben concentrations (80-110%) in their urine than women who reported no use in the past 24 h. Women who used shampoo, conditioner, and cosmetics also showed 70-80% higher butylparaben concentrations in their urine.
Status:
Possibly Marketed Outside US
First approved in 1984
Source:
NADA125933
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
As an aid in the prevention of coccidiosis caused by Eimeria adenoeides, E.gallopavonis, and E.meleagrimitis; for the prevention of bacterial infections caused by Pasteurella multocida (fowl cholera); for the treatment of skin and soft tissue infections. Ormetoprim potentiates the activity of sulfadimethoxine. The in vitro antibacterial spectrum and activity of the 2 compounds are very similar. Sulfonamides competitively inhibit bacterial synthesis of folic acid (pteroylglutamic acid) from paraaminobenzoic acid. Conditions reported following use of sulfonamides or potentiated sulfonamides include polyarthritis, urticaria, facial swelling, fever, hemolytic anemia, polydypsia, polyuria, hepatitis, vomiting, anorexia, diarrhea, and neurologic disorders. In rare instances, neurologic signs including behavioral changes, ataxia, seizures, aggression, and hyperexcitability have been reported. Keratitis sicca, possibly due to prolonged use of sulfonamides, has been reported.
Status:
Possibly Marketed Outside US
Source:
A-TEAM
Source URL:
First approved in 1984
Source:
NU-DERM SUNFADER Skin Lightener with Sunscreen (SPF 15) PABA FREE by OMP, INC.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Butylated hydroxytoluene, commonly known as BHT, is an organic compound that is used in the food, cosmetic, and pharmaceutical industry as an antioxidant. BHT is a substituted derivative of phenol. BHT helps to prevent the formation of free radicals and oxidation. When used in food products, it delays oxidative rancidity of fats and oils, and prevents loss of activity of oil-soluble vitamins. It may be found in pharmaceutical gels, creams and liquid or gelatin capsules, tablets and other pharmaceutical dosage forms. The ability of oral BHT to lead to cancer is a controversial topic, but most food industries have replaced it with butylated hydroxyanisole (BHA). BHT was first used as an antioxidant food additive in 1954. BHT does have other commercial uses, as in animal feeds and in the manufacture of synthetic rubber and plastics, where it also acts as an antioxidant. The U.S. Food and Drug Administration has deemed that BHT is safe enough when used in limited concentrations. It currently permits its use in concentrations of about 0.01% to 0.02% in most foods. As an emulsion stabilizer in shortening, it may be used in a somewhat higher concentration, 200 parts per million.
Status:
Possibly Marketed Outside US
Source:
NCT02418130: Phase 4 Interventional Completed Fatigue
(2014)
Source URL:
First approved in 1984
Source:
NDA019018
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Taurine is a semi-essential amino acid and is not incorporated into proteins. Taurine is considered conditionally essential because it cannot be synthesized by infants younger than 4-6 weeks, and it may not be adequately synthesized in patients receiving long-term parenteral nutrition and patients with short-term hypermetabolic conditions. In mammalian tissues, taurine is ubiquitous and is the most abundant free amino acid in the heart, retina, skeletal muscle, brain, and leukocytes. Taurin occurs naturally in fish and meat. The mean daily intake from omnivore diets was determined to be around 58 mg. Taurine is a component of energy drinks, with many contain 1000 mg per serving. In medicine, taurine supplementation demonstrated efficacy in relieving symptoms of heart failure, hepatitis, hypertension and psychotic disorder. Taurine exerts many physiological functions, including membrane stabilization, osmoregulation and cytoprotective effects, antioxidant and anti-inflammatory actions as well as modulation of intracellular calcium concentration and ion channel function. In addition taurine may control muscle metabolism and gene expression, through yet unclear mechanisms. The cellular and biochemical mechanisms mediating the actions of taurine are not fully known.
Status:
Possibly Marketed Outside US
Source:
FUNGOID TINCTURE TREATMENT KIT-
Source URL:
First approved in 1983
Source:
Dakins Full by Century Pharmaceuticals, Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
HYPOCHLORITE (as sodium salt) is a main active component of DAKIN'S® antimicrobial solution, which is used to prevent and treat infections of the skin and tissue, and also pre- and post-surgery cuts, abrasions, and skin ulcers.