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Search results for vitamin root_mixture_components_substance_refPname in Mixture Component Name (approximate match)
Status:
Possibly Marketed Outside US
Source:
NCT04160767: Phase 4 Interventional Unknown status Celiac Disease
(2019)
Source URL:
First approved in 2010
Source:
21 CFR 352
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
NCT04560283: Phase 4 Interventional Completed Vagina; Anomaly
(2016)
Source URL:
First approved in 2008
Source:
UREA by SOLUTECH PHARMACEUTICALS LLC
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
NADA141349
(2013)
Source URL:
First approved in 2005
Source:
NADA141244
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm071835.htm laxative:stimulant laxative sennosides a and b
Source URL:
First approved in 1998
Source:
21 CFR 334
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
21 CFR 334
(2021)
Source URL:
First approved in 1996
Source:
Armour Thyroid by Allergan, Inc.
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
ORURU by Kaneko, R.|Tsuchiya, T.
Source URL:
First approved in 1990
Source:
21 CFR 352
Source URL:
Class:
MIXTURE
Targets:
Gamma-oryzanol is a naturally occurring component in rice bran and rice germ, which consists of a mixture of ferulic acid esters of sterols and triterpene alcohols. The mechanism of action of gamma-oryzanol is believed to be involved in the metabolism of catecholamine in the hypothalamus. The antioxidant effect of gamma-oryzanol was well documented and excellent in inhibiting lipid peroxidation. Isolation, extraction, and purification of gamma oryzanol were first reported in the mid-1950s. It has been sold in Japan as a medicine since 1962, first to treat anxiety and later in menopause. Gamma oryzanol and rice bran oil therapy have been used to manage elevated cholesterol and triglyceride levels since the late 1980s. No human clinical studies reported adverse effects of rice bran or its fiber fraction.
Status:
Possibly Marketed Outside US
Source:
Calcium Acetate 667 mg by Pharmin USA, LLC
(2008)
Source URL:
First approved in 1979
Source:
ANDA086923
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
21 CFR 334
Source URL:
First approved in 1977
Source:
K PhosNeutral by Beach Products, Inc.
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Class:
MIXTURE
Fusafungine, also known as fusafungin, is a cyclic depsipeptide antibiotic from Fusarium lateririum used for the treatment of nasal and throat infection including sinusitis, rhinitis, rhinopharyngitis, angina, laryngitis, and tracheitis. Fusafungine consists of a mixture of enniatins and has been widely used over the past 50 years. Its first authorization in the EU was in 1963. Fusafungine showed bacteriostatic activity against a suite of microorganisms, such as Mycoplasma pneumoniae, Legionella pneumophila, Streptococcus pneumoniae, S. pyogenes, and Staphylococcus aureus, including methicillin-resistant S. aureus. Besides its bacteriostatic activity against most micro-organisms involved in respiratory tract infections fusafungine displays original anti-inflammatory properties. Fusafungine has multiple mechanisms of action, including downregulation of the expression of intercellular adhesion molecule-1 (ICAM-1) and inhibition of production of proinflammatory cytokines. In September 2015, an EU-wide assessment of the benefit-risk of fusafungine was initiated due to an increase in the reporting rate of serious allergic reactions. European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommended that fusafungine should be withdrawn from the EU market
Status:
Possibly Marketed Outside US
Source:
NCT03701919: Phase 4 Interventional Completed Bariatric Surgery
(2019)
Source URL:
Class:
MIXTURE