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Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2016)
Source URL:
First approved in 2013
Source:
21 CFR 355
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Stevioside is an ent-kaurene type diterpenoid glycoside isolated
from leaves of Stevia rebaudiana (Bertoni) Bertoni, a
perennial herb of the asteraceae (compositae) family.
Stevioside and related compounds are responsible for the
sweet taste of Stevia leaves. Stevioside is an intense sweetener and
the extract of its source (S. rebaudiana) finds extensive use in
countries like Japan, China, Russia, Korea, Paraguay,
Argentina, Indonesia, Malaysia, Australia, New Zealand,
South America, and others, to sweeten local teas, medicines,
food, and beverages. Stevia leaves are also in use
for their medicinal benefits in hypertension, obesity, topical
dressing for wounds, and other skin disorders. Oral stevioside is not taken up by the human body (or
the uptake is extremely low) and none of the digestive
enzymes from the gastro-intestinal tract of different animals
and human body are able to degrade stevioside into steviol. A number of studies have suggested that, beside sweetness, stevioside along with related compounds, which include rebaudioside A, steviol and isosteviol may also offer therapeutic benefits, as they have anti-hyperglycemic, anti-hypertensive, anti-inflammatory, anti-tumor, anti-diarrheal, diuretic, and immunomodulatory actions.
Status:
Possibly Marketed Outside US
Source:
Aspirin with Apple Flavoring by MWI Veterinary Supply, Inc.
(2013)
Source URL:
First approved in 2013
Source:
Aspirin with Apple Flavoring by MWI Veterinary Supply, Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Acetylsalicylsalicylic acid is a commonly occurring impurity in commercial acetylsalicylic acid preparations. It is considered to be immunogenic substance.
Status:
Possibly Marketed Outside US
First approved in 2013
Source:
M017
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Nonivamide is an organic compound and a capsaicinoid. It is an amide of pelargonic acid (n-nonanoic acid) and vanillyl amine. It is present in chili peppers, but is commonly manufactured synthetically. Nonivamide (trade name Finalgon ) is used in topical ointments and creams to relieve minor aches and pains of muscles and joints. Nonivamide is also available in large adhesive bandages that can be applied to the back. Concentrations are typically between 0.025% and 0.075%. Nonivamide is a TRPV1 ion channel agonist.
Status:
Possibly Marketed Outside US
Source:
505G(a)(3)
(2022)
Source URL:
First approved in 2013
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Baicalin is a flavonoid compound with anti-inflammatory and anti-oxidant activity extracted from Scutellarua rivularis. Limited distribution data suggest that baicalin reached several sites such as the brain, eye lens, thymus, etc. Metabolism data suggest the rapid conversion of baicalin to baicalein. Baicalin has the potential to be used in novel anti-cancer therapeutic formulations for treatment of ovarian cancer and other cancers. Baicalin markedly inhibits replication of human immunodeficiency virus type 1 (HIV-1) in a concentration-dependent manner in normal peripheral blood mononuclear cells (PBMC) stimulated with phytohemagglutinin (PHA) in vitro. The preventive medication of baicalin shows a protective effect on C57 BL mouse with Parkinson's disease induced by 1-methyl-4-phenyl-1, 2, 3, 6-tetrahydropyridine (MPTP).
Status:
Possibly Marketed Outside US
Source:
ROBENGATOPE by Photogen Technologies
Source URL:
First approved in 2013
Source:
GloStrips by Nomax Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Rose bengal sodium (RB) is a small molecule, halogenated xanthene being developed by Provectus Biopharmaceuticals (formerly Provectus Pharmaceuticals). It is commonly used in eye drops to stain damaged conjunctival and corneal cells and thereby identify damage to the eye. The stain is also used in the preparation of Foraminifera for microscopic analysis, allowing the distinction between forms that were alive or dead at the time of collection. A form of rose bengal is also being studied as a treatment for certain cancers and skin conditions. The cancer formulation of the drug, known as PV-10, is currently undergoing clinical trials for melanoma and breast cancer. Recently, interest in RB as a therapeutic cancer treatment has increased due to significant anti-tumor responses with direct tumor injection in human clinical trials for metastatic melanoma. In these patients, there has been the implication that RB may mount a T-cell mediated anti-tumor response and impart antigen-specific responses in distant bystander lesions.
Status:
Possibly Marketed Outside US
Source:
Prosoria Psoriasis Treatment by General Foods
Source URL:
First approved in 2012
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Tetrahydrodiferuloylmethane (aka Tetrahydrocurcumin) is a bioactive metabolite of curcumin. It has been shown to have anti-inflammatory, anti-oxidant, anti-cancer, and neuroprotective effects in several in vitro and in vivo models. However, there have been no advances in human trials for these conditions. It should be noted that tetrahydrocurcumin is used in non-medicinal skin care formulations intended for skin whitening, skin soothing, and anti-oxidant effects.
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2011)
Source URL:
First approved in 2011
Source:
21 CFR 348
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Citronellal is one of the main constituents of the essential oil from lemongrass (Cymbopogon). Citronellal is a major isolate from Cymbopogon plants, lemon-scented gum, and lemon-scented tea tree. Citronellal is a well-known plant-derived mosquito repellent. In addition, citronellal is very effective repellent against Sitophilus zeamais. Citronellal showed anticandidal activity against C. albicans and non-albicans species of Candida. Citronellal is effective as an analgesic compound in various rodent pain models, with its action probably mediated by the inhibition of peripheral mediators as well as central inhibitory mechanisms that could be related to its strong antioxidant effect observed in vitro.
Status:
Possibly Marketed Outside US
Source:
NCT01833624: Phase 4 Interventional Unknown status Traumatic and/or Non-traumatic Brain Injury
(2012)
Source URL:
First approved in 2011
Source:
Corvita by Trigen Laboratories, LLC
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
SELENATE ION is a compound containing an oxoanion with selenium in its highest oxidation state of VI. Selenates are analogous to sulfates and have similar chemistry, but unlike sulfate, selenate is a good oxidizer. Selenate is the form required by organisms that need selenium as a micronutrient. These organisms have the ability to acquire, metabolize and excrete selenium. The level at which selenium becomes toxic varies from species to species and is related to other environmental factors like pH and alkalinity that influence the concentration of selenite over selenate. Selenate and other forms of selenium are highest in areas where ancient seas have evaporated. These areas are enriched in selenium and over millennia, biologic adaptation has occurred.
Status:
Possibly Marketed Outside US
Source:
M020
(2011)
Source URL:
First approved in 2011
Source:
M020
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2013)
Source URL:
First approved in 2011
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Ursolic acid is a natural terpene compond found in a wide variety of plants but most well known for being in apple peels. Ursolic acid has a series of biological effects such as sedative, anti-inflammatory, anti-bacterial, anti-diabetic, antiulcer, antitumor etc. Ursolic acid has been shown to target multiple proinflammatory transcription factors, cell cycle proteins, growth factors, kinases, cytokines, chemokines, adhesion molecules, and inflammatory enzymes.
Evidences suggest that ursolic acid could be used as a potential candidate to develop a comprehensive competent strategy towards the treatment and prevention of health disorders.
Although the science is preliminary, it seems to be able to reduce fat accumulation and increase muscle mass gain when in a fed state, and to induce fat burning and preserve muscle mass when in a fasted state.