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Search results for m root_codes_code in Code Literal (approximate match)
Status:
US Previously Marketed
Source:
EXXUA by FABRE KRAMER
(2023)
Source URL:
First approved in 2023
Source:
EXXUA by FABRE KRAMER
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Gepirone (brand name Travivo) is an investigational azapirone antidepressant and anxiolytic drug in development for the treatment of major depressive disorder but has yet to be marketed. Like other azapirones, it acts as a selective partial agonist of the 5-HT1A receptor. Gepirone has been under development in the U.S. in an extended release form (referred to as Gepirone ER). It has been rejected multiple times by the FDA during the drug approval process and Phase III studies evaluating its use in the treatment of MDD were prematurely terminated. These were the initial Phase III studies of gepirone ER in MDD, and the effective dose range had not been determined. In March 2016, the FDA reversed its decision and gave gepirone ER a positive review, clearing the way for the drug to finally gain market approval in the U.S. In addition to its antidepressant and anxiolytic properties, gepirone has been found to improve symptoms of sexual dysfunction in men and women, similarly to the marketed 5-HT1A receptor agonist flibanserin. The pro-sexual effects appear to be independent of its antidepressant and anxiolytic effects. Mechanism of action studies have demonstrated that gepirone possesses a much greater selectivity for 5-HT1A receptors over dopamine D2 receptors. Long-term studies have shown that gepirone has a differential action at presynaptic (agonist) and post-synaptic (partial agonist) 5-HT1A receptors. Treatment with gepirone ER
desensitizes presynaptic 5-HT1A receptors, which decreases serotonin autoregulatory inhibition and enhances activation of postsynaptic 5-HT1A receptors. As a partial agonist gepirone ER acts as an agonist when endogenous serotonin is not present and as an antagonist when endogenous serotonin is present. Overall, gepirone ER increases serotonin production when insufficient amounts are present, and decreases serotonin production when excess amounts are present. Gepirone has been tested in Phase II clinical trial as antidepressant medication for pharmacotherapy for cocaine dependent subjects.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(22)(iv) antifungal:scalp or nails camphorated metacresol
Source URL:
First approved in 1982
Source:
BLA018780
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Metacresol (m-cresol or 3-methylphenol) is colorless, yellowish liquid. It is used as a bactericide for control of crown gall and olive knot on certain fruit and nut trees and ornamentals and the genetic/physiological disorder burr knot on apples. Currently, one product is registered which contains both m-cresol and xylenol. Used as disinfectant/bacteriocide/germicide for animal pathogenic bacteria (G- and G+ vegetative) in households, sickrooms, hospitals, veterinary clinics, and veterinary hospitals; on surgical instruments, diagnostic instruments/equipment and on hospital critical rubber/plastic items. Used as an insecticide and miticide on dogs for treatment of lice and fleas. It is also used for making synthetic resins; in photographic developers, explosives. Additionally, m-cresol is chemical intermediate for thymol used in cough/cold medicinals, synthetic pyrethroid insecticides, 3-methyl-6-t-butylphenol, trinitro-m-cresol for explosives, and phenolic resins; disinfectant ingredient; ore flotation agent; solvent. m-Cresol, either pure or mixed with p-cresol, is important in the production of contact herbicides. m-Cresol is also a precursor to the pyrethroid insecticides. Furthermore, many flavor and fragrance compounds, such as (-)-methanol and musk ambrette, are derived from m-cresol. Several important antioxidants including synthetic vitamin E are produced from m-cresol. m-cresol is used as a topical dental antiseptic. m-cresol is an effective antimicrobial preservative and is used at low levels (0.3%) in multi-dose peptide and protein formulations. m-cresol has been shown to cause protein aggregation.
Status:
Possibly Marketed Outside US
Source:
BEAUTIFUL WOMANS HAIR LOVES COLORFUL BUBBLES HAIR DYE 3N DARK BROWN by Modlina Cosmetics Co., Ltd
(2013)
Source URL:
First approved in 2013
Source:
BEAUTIFUL WOMANS HAIR LOVES COLORFUL BUBBLES HAIR DYE 3N DARK BROWN by Modlina Cosmetics Co., Ltd
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2021)
Source URL:
First approved in 2010
Source:
Aquax Repellent by Pella Pharmaceuticals Co. Ltd
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Other
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
BLA103189
(2009)
Source URL:
First approved in 2009
Source:
BLA103189
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
Possibly Marketed Outside US
Source:
M020
(2000)
Source URL:
First approved in 2000
Source:
M020
Source URL:
Class:
STRUCTURALLY DIVERSE