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Status:
Possibly Marketed Outside US
Source:
M008
(2000)
Source URL:
First approved in 1959
Source:
NDA011961
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
D&C Red No. 27 are fluorescein-based dyes that were approved in 1982 for use in drugs and cosmetics Cosmetic retail products containing this dye is primarily lipsticks and blushers. D&C Red No. 27 physically associated with non-aqueous aluminum or zirconium minerals (lakes) and used in lipsticks, blushers, make-up preparations, hair dyes and colors, rouges and face powders. The FDA lists D&C Red No. 27 as a safe additive for drugs and cosmetics as per FDA standards.
Status:
Possibly Marketed Outside US
Source:
21 CFR 341
(1958)
Source URL:
First approved in 1958
Source:
21 CFR 341
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Status:
Possibly Marketed Outside US
Source:
NDA208742
(1958)
Source URL:
First approved in 1958
Source:
NDA208742
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
Possibly Marketed Outside US
Source:
M017
(2021)
Source URL:
First approved in 1958
Source:
21 CFR 333C
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
Cetacaine Anesthetic by Cetylite Industries, Inc.
(1960)
Source URL:
First approved in 1958
Source:
Cetacaine Anesthetic by Cetylite Industries, Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Mecetronium etilsulfate (MES) is a detergent and belongs to the group of surface-active ingredients. MES along with propan-2-ol and propan-1-ol is an ingredient of rub-in hand disinfectants. The antimicrobial contribution of MES in hand rubs is questionable. MES locks on the outermost layer of the skin (stratum corneum) for sustained bacterial reduction as long as 3 to 5 hours.
Status:
Possibly Marketed Outside US
Source:
NCT04704518: Phase 4 Interventional Completed Photorefractive Keratectomy
(2022)
Source URL:
First approved in 1958
Source:
NDA210274
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Trehalose, a naturally occurring disaccharide of glucose that appears to function in an anhydrobiotic capacity in many organisms. Bioblast Pharma study trehalose in Phase 2 for treating patients with Oculopharyngeal Muscular Dystrophy (OPMD) and spinocerebellar ataxia, type 3. In OPMD trehalose prevents the aggregation of the pathological protein (PABPN1) in muscle cells, the hallmark of the disease, by stabilizing the protein, reducing the formation of protein aggregations, and promoting their clearance from cells through autophagy, thus preventing muscle cell death. Trehalose induces autophagy via mTOR independent pathway. It activates TFEB, a master controller of lysosomal biogenesis and autophagy, by inhibiting AKT which is a negative regulator of TFEB that acts by direct phosphorylation (and inhibition) of TFEB. In addition, trehalose protects cells from hypoxic and anoxic injury and suppresses protein aggregation. In vivo studies with trehalose show cellular and behavioral beneficial effects in animal models of neurodegenerative diseases. Trehalose was in phase III clinical trial to study if it was possible to use the drug as add-on therapy in Bipolar Depression. Also in combination with hyaluronate, it can be used to treat dry eye syndrome. Trehalose protects the epithelial cells on the ocular surface, improving their resistance to the daily stresses of dry environments and tear film changes in a dry eye.
Status:
Possibly Marketed Outside US
Source:
21 CFR 333E
(2020)
Source URL:
First approved in 1958
Source:
NDA208912
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Acetyltriethyl citrate (ATEC, Acetyl Triethyl Citrate) is a water-soluble plasticizer used in pharmaceutical plasticized polymers. It is an aliphatic ester of citric acid which is a clear oily liquid with essentially no odor.
In pharmaceutical polymers, ATEC is used as a hydrophilic plasticizer in the coating of press-coated. tablets that are composed of hydroxypropyl methylcellulose acetate succinate or enteric polymer
films consisting of polymethacrylic acid methylmethacrylate. ATEC is also used in protein
films composed of whey protein or sunflower protein for buccal and sublingual films or particulate
systems. Acetyl Triethyl Citrate and Acetyl Tributyl Citrate are used in nail products at concentrations up to 7%. In a guinea pig maximization test, Acetyl Triethyl Citrate was a sensitizer whereas Acetyl Tributyl Citrate was not. Limited clinical testing of Acetyl Triethyl Citrate and Acetyl Tributyl Citrate was negative for both skin irritation and sensitization. Physiologic effects noted with intravenous delivery of Acetyl Triethyl Citrate or Acetyl Tributyl Citrate include dose-related decreases in blood pressure and intestinal muscular spasms.
Status:
Possibly Marketed Outside US
Source:
SALLY HANSEN MICROWAVABLE EYBROW, FACE AND LIP WAX KIT
Source URL:
First approved in 1958
Source:
21 CFR 333C
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Status:
Possibly Marketed Outside US
Source:
ANDA078671
(2008)
Source URL:
First approved in 1958
Source:
21 CFR 333C
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
First approved in 1958
Source:
Cetacaine Anesthetic by Cetylite Industries, Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Butamben is a local anesthetic. It is the ester of 4-aminobenzoic acid and butanol. It is one of three components in the topical anesthetic Cetacaine. The onset of Cetacaine-produced anesthesia is rapid (approximately 30 seconds) and the duration of anesthesia is typically 30-60 minutes, when used as directed. This effect is due to the rapid onset, but short duration of action of Benzocaine coupled with the slow onset, but extended duration of Tetracaine HCI and bridged by the intermediate action of Butamben.