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Restrict the search for
vitamin a
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Status:
US Approved Rx
(2019)
Source:
ANDA212172
(2019)
Source URL:
First marketed in 1894
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Methenamine is an antibacterial agent for preventing recurrent urinary tract infection. It can be used as methenamine hippurate or methenamine mandelate preparations and is United States Food and Drug Administration-approved. Methenamine exerts its activity because it is hydrolyzed to formaldehyde in acid urine.
Status:
US Approved Rx
(2021)
Source:
ANDA214864
(2021)
Source URL:
First marketed in 1880
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Betaine is a methyl derivative of glycine first isolated from the juice of sugar beets. Betaine is found in many common foods, but concentrated significantly in beets, spinach, wheat foods, and shellfish. In addition, betaine can be synthesized within the human body. Betaine participates in the methionine cycle, which produces vital biomolecules including proteins, hormones, phospholipids, polyamines, and nutrients. Betaine is used as a dietary supplement and has a beneficial effect on the human health. In the USA, FDA approved a betaine-containing drug Cystadane for the treatment of homocystinuria. The drug acts as a methyl group donor in the remethylation of homocysteine to methionine.
Status:
US Approved Rx
(2013)
Source:
NDA206023
(2013)
Source URL:
First marketed in 1868
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Oxygen is a chemical element with atomic number 8. Diatomic oxygen constitutes 20.8% of the Earth's atmosphere. Diatomic oxygen is used by complex life forms such as animals, in cellular respiration. Medical oxygen is widely used in clinical practice to provide a basis for most modern anaesthetic techniques; to restore the tissue oxygen tension towards normal by improving oxygen availability in a wide range of conditions such as shock, severe haemorrhage, coronary occlusion, carbon monoxide poisoning, major trauma; to aid the resuscitation of the critically ill, when the circulation is impaired; to aid in neonatal resuscitation; to treat acute severe headache in adults diagnosed with cluster headache.
Status:
US Approved Rx
(2017)
Source:
NDA209963
(2017)
Source URL:
First marketed in 1860
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Cocaine is an alkaloid ester extracted from the leaves of plants including coca. Cocaine is a local anesthetic and vasoconstrictor and is clinically used for that purpose, particularly in the eye, ear, nose, and throat. It also has powerful central nervous system effects similar to the amphetamines and is a drug of abuse. Cocaine, like amphetamines, acts by multiple mechanisms on brain catecholaminergic neurons; the mechanism of its reinforcing effects is thought to involve inhibition of dopamine uptake. Cocaine is addictive due to its effect on the reward pathway in the brain. After a short period of use, there is a high risk that dependence will occur. Its use also increases the risk of stroke, myocardial infarction, lung problems in those who smoke it, blood infections, and sudden cardiac death. Cocaine sold on the street is commonly mixed with local anesthetics, cornstarch, quinine, or sugar which can result in additional toxicity. Following repeated doses, a person may have decreased the ability to feel pleasure and be very physically tired. Cocaine acts by inhibiting the reuptake of serotonin, norepinephrine, and dopamine. This results in greater concentrations of these three neurotransmitters in the brain. It can easily cross the blood-brain barrier and may lead to the breakdown of the barrier.
Status:
US Approved Rx
(2013)
Source:
NDA205704
(2013)
Source URL:
First marketed in 1844
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Nitrous oxide (N2O, laughing gas) was first discovered by the English scientist Joseph Priestly and has been used for more than 150 years. It has remained one of the most widely used anesthetics in both dental and medical applications. This small and simple inorganic chemical molecule has indisputable effects of analgesia, anxiolysis, and anesthesia that are of great clinical interest. As a general anesthetic, it is very weak and is generally not used as a single agent. It may be used as a carrier gas with oxygen in combination with more potent general inhalational gases for surgical anesthesia. In dentistry, it is commonly used as a single agent (with oxygen) for partial sedation, most commonly in pediatric dental populations. Findings to date indicate that the analgesic effect of N2O is opioid in nature, and, like morphine, may involve a myriad of neuromodulators in the spinal cord. The anxiolytic effect of N2O, on the other hand, resembles that of benzodiazepines and may be initiated at selected subunits of the gamma-aminobutyric acid type A (GABA(A)) receptor. Similarly, the anesthetic effect of N2O may involve actions at GABA(A) receptors and possibly at N-methyl-D-aspartate receptors as well.
Status:
US Approved Rx
(2013)
Source:
NDA204223
(2013)
Source URL:
First marketed in 1827
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Morphine is one of the most important and widely used opioid for the treatment of chronic and acute pain: the very wide interindividual variability in the patients’ response to the drug may have genetic derivations. Sulphate salt of morphine sold under the many brand names, one of them, DURAMORPH, which is indicated for the management of pain severe enough to require use of an opioid analgesic by intravenous administration, and for which alternative treatments are not expected to be adequate. In addition for the epidural or intrathecal management of pain without attendant loss of motor, sensory, or sympathetic function. Morphine is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of morphine is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with morphine. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug. Morphine has a high potential for addiction and abuse. Common side effects include drowsiness, vomiting, and constipation. Caution is advised when used during pregnancy or breast-feeding, as morphine will affect the baby.
Status:
US Approved Rx
(2018)
Source:
NDA207987
(2018)
Source URL:
First marketed in 0652
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Alcohols exhibit rapid broad-spectrum antimicrobial activity against vegetative bacteria (including mycobacteria), viruses, and fungi but are not sporicidal. They are, however, known to inhibit sporulation and spore germination, but this effect is reversible. Because of the lack of sporicidal activity, alcohols are not recommended for sterilization but are widely used for both hard-surface disinfection and skin antisepsis. Lower concentrations may also be used as preservatives and to potentiate the activity of other biocides. Many alcohol products include low levels of other biocides (in particular chlorhexidine), which remain on the skin following evaporation of the alcohol, or excipients (including emollients), which decrease the evaporation time of the alcohol and can significantly increase product efficacy. Ethanol in combination with: chlorhexidine gluconate 1% was approved to use in surgical hand antiseptic. It significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care. Ethanol is also used as a co-solvent to dissolve many insoluble drugs and to serve as a mild sedative in some medicinal formulations. Ethanol is metabolized by the hepatic enzyme alcohol dehydrogenase. Ethanol affects the brain’s neurons in several ways. It alters their membranes as well as their ion channels, enzymes, and receptors. Alcohol also binds directly to the receptors for acetylcholine, serotonin, GABA, and the NMDA receptors for glutamate. The sedative effects of ethanol are mediated through binding to GABA receptors and glycine receptors (alpha 1 and alpha 2 subunits). It also inhibits NMDA receptor functioning. In its role as an anti-infective, ethanol acts as an osmolyte or dehydrating agent that disrupts the osmotic balance across cell membranes.
Status:
US Approved OTC
Source:
21 CFR 341.16(g) cough/cold:bronchodilator racepinephrine hydrochloride
Source URL:
First approved in 2000
Source:
M012
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Racepinephrine or racemic epinephrine is a mixture of levo and dextro isomers of epinephrine act as a nonselective agonist at adrenergic receptors. It is a bronchodilator used in the temporary relief of mild symptoms of intermittent asthma including wheezing, shortness of breath. Inhaled racepinephrine became available in September 2012 as a nonprescription treatment for bronchospasm based on a 1986 US Food and Drug Administration rule. Besides, racemic epinephrine relieves respiratory distress in hospitalized infants with bronchiolitis and is safe but does not abbreviate hospital stay. Morbidity associated with bronchiolitis as identified by parents persists for at least one week after hospital discharge in most infants.
Status:
US Approved OTC
Source:
21 CFR 333.310(a) acne benzoyl peroxide
Source URL:
First approved in 1984
Source:
NDA050557
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Benzoyl peroxide (BPO) is an organic compound in the peroxide family. It consists of two benzoyl groups bridged by a peroxide link. It is one of the most important organic peroxides in terms of applications and the scale of its production. Benzoyl peroxide is used as an acne treatment, for bleaching hair and teeth. Adverse reactions are: dryness and urticarial reaction, contact dermatitis, application site burning, application site irritation and skin irritation.
Status:
US Approved OTC
Source:
21 CFR 341.20(b)(7) cough/cold:nasal decongestant oxymetazoline hydrochloride
Source URL:
First approved in 1964
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Oxymetazoline is an adrenergic alpha-agonist, direct acting sympathomimetic, used as a vasoconstrictor to relieve nasal congestion The sympathomimetic action of oxymetazoline constricts the smaller arterioles of the nasal passages, producing a prolonged (up to 12 hours), gentle and decongesting effect. Oxymetazoline elicits relief of conjunctival hyperemia by causing vasoconstriction of superficial conjunctival blood vessels. The drug's action has been demonstrated in acute allergic conjunctivitis and in chemical (chloride) conjunctivitis. Oxymetazoline is self-medication for temporary relief of nasal congestion associated with the common cold, hay fever, or other upper respiratory allergies. Oxymetazoline is available over-the-counter as a topical decongestant in the form of oxymetazoline hydrochloride in nasal sprays such as Afrin, Operil, Dristan, Dimetapp, oxyspray, Facimin, Nasivin, Nostrilla, Sudafed OM, Vicks Sinex, Zicam, SinuFrin, and Mucinex Full Force. Due to its vasoconstricting properties, oxymetazoline is also used to treat nose bleeds and eye redness.