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Status:
US Approved Rx
(2012)
Source:
ANDA202700
(2012)
Source URL:
First approved in 1998
Source:
NDA020717
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Armodafinil is the R-enantiomer of modafinil, a wake-promoting agent, that primarily affects areas of the brain involved in controlling wakefulness. Armodafinil is an indirect dopamine receptor agonist; both armodafinil and modafinil bind in vitro to the dopamine transporter and inhibit dopamine reuptake. Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Once-daily armodafinil was generally well tolerated in adult patients with excessive sleepiness associated with OSA (despite treatment of the underlying condition), narcolepsy or SWSD.
Status:
US Approved Rx
(1997)
Source:
ANDA074626
(1997)
Source URL:
First approved in 1978
Source:
STADOL PRESERVATIVE FREE by APOTHECON
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Butorphanol is a synthetic opioid agonist-antagonist analgesic with a pharmacological and therapeutic profile that has been well established since its launch as a parenteral formulation in 1978. The introduction of a transnasal formulation of butorphanol represents a new and noninvasive presentation of an analgesic for moderate to severe pain. This route of administration bypasses the gastrointestinal tract, and this is an advantage for a drug such as butorphanol that undergoes significant first-pass metabolism after oral administration. The onset of action and systemic bioavailability of butorphanol following transnasal delivery are similar to those after parenteral administration. Butorphanol blocks pain impulses at specific sites in the brain and spinal cord. Butorphanol has agonistic activity at the κ-receptor and antagonistic activity at the μ-receptor. It also exhibits partial agonistic activity at the σ-receptor.
Status:
US Approved Rx
(2022)
Source:
ANDA214745
(2022)
Source URL:
First approved in 1963
Source:
NDA013263
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Diazepam is a benzodiazepine first discovered at Hoffman-La Roche in the late 1950s. Diazepam was approved by FDA for the treatment of anxiety disorders as well as for such conditions as skeletal muscle spasm, alcohol withdrawal syndrom and convulsions (under the most known brand Valium). The drug acts by binding to GABA-A receptors and potentiating GABA evoked current. Chronic diazepam use is associated with tolerance, dependence, and withdrawal.
Status:
Investigational
Source:
NCT00955747: Phase 3 Interventional Completed Type 2 Diabetes
(2007)
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Tagatose is a functional sweetener. It is naturally occurring and often found in dairy products. Tagatose is similar in texture and sweetness to sucrose (table sugar) but with only 38% of the calories. It is approved for use as a food additive as a low-calorie sweetener. Only 15 - 20 % of Tagatose is absorbed in the small intestines and metabolized similarly to sucrose; the bulk of ingested tagatose is fermented in the colon by bacteria producing short chain fatty acids which are subsequently absorbed and metabolized by the body without affecting insulin levels. Tagatose is being investigated by Spherix for the treatment of obesity and type II diabetes. Tagatose consumed orally significantly blunts the rise in plasma glucose seen after oral glucose in patients with diabetes mellitus in a dose-dependent manner without significantly affecting insulin levels. It has been suggested that Tagatose may act by attenuating the absorption of glucose in the intestines.
Status:
US Approved Allergenic Extract
(1994)
Source:
BLA103738
(1994)
Source URL:
First approved in 1990
Source:
M032
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Cinnamaldehyde is one of the active compounds
found in cinnamon. It was reported that cinnamaldehyde has anti-diabetic, anti-cancer, antimicrobial and anti-inflammatiry activity. Cinnamon is a common prescription compound in traditional Chinese medicine and it is used as a dietary supplement all over the world. Cinnamon dietary supplement Cinnamonforce (min. 35% cinnamaldehyde) was tested in phase II clinical trials and demonstrated therapeutic activity in patients with type 2 diabetes. The mechanism of cinnamaldehyde possibly involves the activation of PPAR gamma/delta receptors. Cinnamaldehyde is partially metabolized into cinnamic acid in the stomach and small intestine, and is almost completely metabolized into cinnamic acid in the liver. Cinnamic acid is believed to be the active metabolite, which is responsible for anti-diabetic properties of cinnamaldehyde.
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:
21 CFR 352
(2023)
Source URL:
First approved in 2020
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Acetophenone is an organic compound with major use in the chemical industry for the polymerization of olefins, and organic synthesis as a photosensitizer and as a specialty solvent for plastics and resins. It is also a chemical intermediate for the odorant ethyl methyl phenylglycidate, the riot control agent 2-chloroacetophenone and 2- bromoacetophenone for dyes. It is used in the manufacture of pharmaceuticals, rubber, dyes, and corrosion inhibitors. Acetophenone was approved by the FDA as a flavoring substance and adjuvant in food. It is used as a flavoring agent in non-alcoholic beverages, ice cream, candy, baked goods, gelatins, puddings, tobacco, and chewing gum. It is used to impart an orange-blossom fragrance in soaps, detergents, creams, lotions, and perfumes.
Status:
Possibly Marketed Outside US
Source:
KETOSEB by Ceva Sante Animale
(2016)
Source URL:
First approved in 2016
Source:
KETOSEB by Ceva Sante Animale
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Status:
First approved in 2011
Source:
21 CFR 348
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Vanillyl butyl ether is an ether of monohydroxybenzoic acid. It is added to food products as a flavoring agent. It has a characteristic trigeminal, burning, hot pepper nature and can be used in spice flavors like pepper, cinnamon and ginger. It is also present in cosmetics and personal care products as a fragrance ingredient, oral care agent, hair conditioning agent, and warming or cooling agent. Vanilloids contain vanillyl groups that bind to the transient receptor potential type V1 channel (Vanilloid receptor-1, TRPV1) that respond to noxious stimuli such as high temperatures and acidic pH. This causes neurons to release glutamate, adenosine triphosphate (ATP) and a variety of neuropeptides, resulting in the warming sensation. Vanillyl butyl ether causes serious eye irritation and may cause an allergic skin reaction.
Status:
US Approved Rx
(2012)
Source:
ANDA202700
(2012)
Source URL:
First approved in 1998
Source:
NDA020717
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Armodafinil is the R-enantiomer of modafinil, a wake-promoting agent, that primarily affects areas of the brain involved in controlling wakefulness. Armodafinil is an indirect dopamine receptor agonist; both armodafinil and modafinil bind in vitro to the dopamine transporter and inhibit dopamine reuptake. Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Once-daily armodafinil was generally well tolerated in adult patients with excessive sleepiness associated with OSA (despite treatment of the underlying condition), narcolepsy or SWSD.