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Status:
Possibly Marketed Outside US
Source:
ANDA209074
(2024)
Source URL:
First approved in 2013
Source:
21 CFR 346
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Potassium Methylparaben is a preservative allowed for use in cosmetic products. Preservative, bactericide, fungicide in cosmetics and pharmaceuticals..
Status:
Possibly Marketed Outside US
Source:
21 CFR 333D
(2013)
Source URL:
First approved in 2013
Source:
21 CFR 333D
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
M016
(2013)
Source URL:
First approved in 2013
Source:
M016
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Edetate dipotassium is a salt of edetic acid (ethylenediaminetetraacetic acid or EDTA). It is used in pharmaceutical formulations (excipient ingredient), cosmetics and foods as chelating agent.
Status:
Possibly Marketed Outside US
Source:
21 CFR 355
(2013)
Source URL:
First approved in 2013
Source:
21 CFR 355
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Stevioside, an abundant component of Stevia rebaudiana leaf, has become well-known for its intense sweetness (250-300 times sweeter than sucrose) and is used as a non-caloric sweetener in several countries. Steviol and isosteviol (metabolic components of stevioside) may offer therapeutic benefits, as they have anti-hyperglycemic, anti-hypertensive, anti-inflammatory, anti-tumor, anti-diarrheal, diuretic, and immunomodulatory actions. In the presence of 16.7 mM glucose both stevioside and steviol enhance insulin secretion from incubated islets in a dose-dependent manner (1 nM to 1 mM). Even though both
stevioside and steviol possess an insulinotropic/anti-hyperglycemic
effect, steviol is more potent than stevioside. Steviol is an inhibitor of hOAT1 and hOAT3 organic anion transporters. Human organic anion transporter hOAT1 belongs to a superfamily of organic anion transporters, which play critical roles in the body disposition of clinically important drugs including anti-HIV therapeutics, anti-tumor drugs, antibiotics, anti-hypertensives, and anti-inflammatories. Highly purified steviol glycosides have repeatedly received Generally Recognized As Safe (GRAS) status from the US Food and Drug Administration in the past (FDA).
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:
21 CFR 358H
(2013)
Source URL:
First approved in 2013
Source:
21 CFR 358H
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Bakuchiol is a prenylated phenolic monoterpene isolated from Psoralea corylifolia Leguminosae, widely used in Chinese and Indian traditional medicine for the treatment of premature ejaculation, knee pain, alopecia spermatorrhea, enuresis, backache, pollakiuria, vitiligo, callus, and psoriasis. Bakuchiol is shown to have anti-microbial, anti-inflammatory, anti-oxidative, anti-osteoporosis, and anti-depression or anti-stress activities The anti-cancer potential of bakuchiol has been. Bakuchiol inhibits liver cancer cell growth through inducing S phase arrest, caspase 9/3 activation, p53 and Bax up-regulation, as well as Bcl-2 down-regulation. It also inhibits human carboxylesterase 2, which is commonly expressed in tumor tissue and involved in the metabolism of endogenous lipids and drugs.
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2013)
Source URL:
First approved in 2013
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
LipoGel CR Base by Southeastern Medical Technologies
(2013)
Source URL:
First approved in 2013
Source:
LipoGel CR Base by Southeastern Medical Technologies
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2013)
Source URL:
First approved in 2013
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2013)
Source URL:
First approved in 2013
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Zeatin is a cytokinin plant growth factor, which has gerontomodulatory, youth preserving and anti-aging effects on serially passaged human adult skin fibroblasts undergoing aging in vitro.