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Showing 1 - 2 of 2 results
Status:
US Approved Rx
(2008)
Source:
ANDA077505
(2008)
Source URL:
First approved in 1999
Source:
NDA020859
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Zaleplon is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class and is indicated for the short-term treatment of insomnia. While Zaleplon is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties, it interacts with the gamma-aminobutyric acid-benzodiazepine (GABABZ) receptor complex. Subunit modulation of the GABABZ receptor chloride channel macromolecular complex is hypothesized to be responsible for some of the pharmacological properties of benzodiazepines, which include sedative, anxiolytic, muscle relaxant, and anticonvulsive effects in animal models. Zaleplon also binds selectively to the CNS GABAA-receptor chloride ionophore complex at benzodiazepine(BZ) omega-1 (BZ1, ο1) receptors. Zaleplon exerts its action through subunit modulation of the GABABZ receptor chloride channel macromolecular complex. Zaleplon also binds selectively to the brain omega-1 receptor located on the alpha subunit of the GABA-A/chloride ion channel receptor complex and potentiates t-butyl-bicyclophosphorothionate (TBPS) binding. Zaleplon is marketed under the brand names Sonata, Starnoc, and Andante.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(i)(B) skin protectant:w/ sales less than $25,000 stearyl alcohol
Source URL:
First approved in 1970
Source:
Ala Quin by Crown Laboratories
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Stearyl Alcohol is long chain fatty alcohol. Stearyl alcohol is prepared from stearic acid or some fats by the process of catalytic hydrogenation. It has low toxicity. Stearyl Alcohol is used in surface-active agents, lubricants, emulsions, resins, and USP ointments and as a substitute for cetyl alcohol and antifoaming agents. Stearyl Alcohol (synthetic) has been approved as a direct food additive (DFA) ingredient, to be used under the same manufacturing practices as the natrual alcohol product. It also has indirect food additive (IFA) status for use in food containers. Stearyl Alcohol is also used as an ingredient in over-the-counter (OTC) drugs of the miscellaneous external drug product category. It is considered to be safe at a concentration of 8 percent or less. Stearyl Alcohol is used in cosmetics as an emollient, stabilizer, antifoaming agent, emulsifier, and carrier. It is used as a water in oil (w/o) emulsifier to produce firm cosmetic products at ordinary temperatures.