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Status:
Possibly Marketed Outside US
First approved in 2009
Source:
ANADA200075
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Salinomycin Sodium is active against certain Gram-positive bacteria, while Gram-negative species are resistant. The use of Salinomycin Sodium as a feed additive at the proposed concentration is unlikely to increase shedding of Salmonella, Escherichia coli, and Campylobacter or to induce resistance and cross-resistance to antimicrobials important in human and animal therapy. Salinomycin Sodium is safe for chickens for fattening at a concentration of 70 mg/kg complete feed with a margin of safety of 1.7. For chickens reared for laying, 50 mg Salinomycin Sodium /kg complete feed is considered safe for a feeding period of the first 12 weeks of life; a margin of safety cannot be given. The simultaneous use of Salinomycin Sodium and certain antibiotic drugs (e.g. tiamulin) is contraindicated. Salinomycin Sodium is absorbed to a certain extent in the chicken and extensively metabolized. Unchanged Salinomycin Sodium represents a very small fraction of the metabolites in tissue and excreta. Many metabolites, predominantly mono- and multi-hydroxylated, have been identified in tissues and excreta. The metabolites in excreta showed a higher degree of hydroxylation than in the liver. Salinomycin -related metabolites have a reduced ionophoric activity when compared with Salinomycin. Salinomycin is considered the MR; ratios of MR to total residue are available for all relevant tissues for 1 and 6 h withdrawal. No residues eggs are expected provided that the proposed maximum dose and duration of administration are respected.
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2020)
Source URL:
First approved in 2009
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 333D
(2010)
Source URL:
First approved in 2009
Source:
21 CFR 333D
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Farnesol, (2E,6E)- is an isoprenoid found in many aromatic plants and is also produced in humans, where it acts on numerous nuclear receptors and has received considerable attention due to its apparent anticancer properties. Farnesol is present in many essential oils such as citronella, neroli, cyclamen, lemon grass, tuberose, rose, musk, balsam, and tolu. It is used in perfumery to emphasize the odors of sweet floral perfumes. Its method of action for enhancing perfume scent is as a co-solvent that regulates the volatility of the odorants. It is especially used in lilac perfumes. Farnesol is a natural pesticide for mites and is a pheromone for several other insects. In a 1994 report released by five top cigarette companies, farnesol was listed as one of 599 additives to cigarettes. Farnesol has been suggested to function as a chemopreventative and anti-tumor agent. Farnesol is subject to restrictions on its use in perfumery as some people may become sensitized to it, however, the evidence that farnesol can cause an allergic reaction in humans is disputed.
Status:
Possibly Marketed Outside US
Source:
NDA022408
(2011)
Source URL:
First approved in 2009
Source:
NDA019918
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Stearalkonium chloride, a safe surfactant with antimicrobial properties, which is used in cosmetic products at concentrations of ≤0.1 to 5%.
Status:
Possibly Marketed Outside US
First approved in 2009
Source:
NADA034393
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Clopidol is an anticoccidial drug used in chickens and turkeys in oredr to prevent coccidiosis and leucocytozoonosis. The drug is approved by FDA and is marketed under the names Coyden 25 and Lerbek 25 (in combination with methylbenzoquate).
Status:
Possibly Marketed Outside US
First approved in 2009
Source:
MIF900001
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Domperidone is a peripherally selective D2 receptor antagonist. It acts as an antiemetic and a prokinetic agent through its effects on the chemoreceptor trigger zone and motor function of the stomach and small intestine. Domperidone was not approved in USA due to risks of cardiac arrhythmias, cardiac arrest, and sudden death, but is available in other countries. However, FDA allows access to Domperidone through an expanded access investigational new drug application (IND) to patients with gastroesophageal reflux disease with upper GI symptoms, gastroparesis, and chronic constipation. As an “off-label” use, domperidone is prescribed to breastfeeding women to enhance their milk production.
Status:
Possibly Marketed Outside US
Source:
Theracodeine-300 by Physician Therapeutics Llc
Source URL:
First approved in 2009
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
γ-aminobutyric acid (GABA), a naturally occurring substance, which is a product of decarboxylation of the amino acid glutamate mediated by the synthesizing enzyme glutamic acid decarboxylase. GABA is a major inhibitory neurotransmitter of the brain and acts mainly through the GABAA receptor (GABAAR). GABA is locally produced by the pancreatic beta cells. GABAARs are also expressed in various immune cells, including T-cells, peripheral blood mononuclear cells, and are known to exert immune-inhibitory effects. Recently was studied, that GABA has the potential in treatment of Type I Diabetes. Moreover, was shown, that GABA administration could enhance immunity under stress conditions.
Status:
Possibly Marketed Outside US
First approved in 2009
Source:
IQQU Acne Serum by IQQU USA Co.
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
L-carnitine (L-beta-hydroxy-gamma-N,N,N-trimethylaminobutyric acid) is conditionally necessary for mitochondrial transport and metabolism of long-chain fatty acids, and thus for myocardial energetic metabolism. D-carnitine is not biologically active and might interfere with proper utilization of the L isomer, and so there are claims that the racemic mixture (DL-carnitine) should be avoided. The pharmacological effects of carnitine are stereospecific: L-carnitine was effective in various animal and clinical studies, while D- and DL-carnitine was found to be ineffective or even toxic to some cells and tissues, such as muscle cells and the myocardium. DL-carnitine caused symptoms of myasthenia and cardiac arrhythmias, which disappeared after L-carnitine administration.
Status:
Possibly Marketed Outside US
Source:
Kaydia Patch by Strong Current Enterprises Limited
Source URL:
First approved in 2009
Source:
21 CFR 348
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Curcumin is a bright yellow chemical produced by some plants, for example, it is the principal curcuminoid of turmeric. It is sold as a food flavoring, food colorant, herbal supplement, and cosmetic ingredient. Although curcumin has been widely studied it has not been officially endorsed for any pharmaceutical use due to issues of stability and bioavailability; although it continues to b marketed as a health supplement. Curcumin has been investigated for the treatment of a number of cancers, asthma, mucositis, schizophrenia, mild cognitive impairment, and depression.
Status:
Possibly Marketed Outside US
Source:
21 CFR 347
(2010)
Source URL:
First approved in 2009
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
The oil obtained from the seeds of the castor oil plant Ricinus communis is one of the oldest drugs known to man. Castor oil is known primarily as an effective laxative; however, it was also used in ancient times with pregnant women to induce labor. Aside from getting rid of acne, castor oil also helps detoxify the skin. It helps break up the oils that clog glands and pores on the face. Only now, have scientists at the Max Planck Institute for Heart and Lung Research succeeded in unravelling the mysteries of the action mechanism. Ricinoleic acid released from the oil in the intestine, is responsible for the analgesic and anti-inflammatory effects. It was discovered, that G protein-coupled receptors, a large group of receptors in the body involved primarily in transmitting signals in cells. Hundreds of receptors were systematically turned off, and then the reaction of the cells to ricinoleic acid was tested. Ultimately, was succeeded identified the key receptor with the name EP3. There was concluded that after being released from the castor oil, the ricinoleic acid is first of all absorbed by the body via the intestinal mucosa; the EP3 receptor then becomes active on the muscle cells of the intestine and uterus, which in turn stimulates intestinal activity.