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Status:
Possibly Marketed Outside US
Source:
21 CFR 333C
(2014)
Source URL:
First approved in 1984
Source:
ANDA209351
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
ISOAMYL ACETATE is an organic compound that is the ester formed from isoamyl alcohol and acetic acid. It is present in many fruit aromas, especially banana, and is used in banana flavoring. It is a clear colorless liquid that is only slightly soluble in water, but very soluble in most organic solvents.
Status:
Possibly Marketed Outside US
Source:
ANDA209351
(1984)
Source URL:
First approved in 1984
Source:
ANDA209351
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
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:
NDA217469
(1983)
Source URL:
First approved in 1983
Source:
NDA217469
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
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.
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2005)
Source URL:
First approved in 1983
Source:
21 CFR 358A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Isopropyl Isostearate is the ester of Isopropyl Alcohol and Isostearic Acid used in beauty products as an emollient, skin conditioning agent, binder and humectant. Isopropyl Isostearate is ideal for heat sensitive personal care formulations. It enables superior odour and colour end-products. It also exhibits excellent skin feel without feel of greasiness.