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Status:
US Approved Rx
(2022)
Source:
ANDA215634
(2022)
Source URL:
First marketed in 1934
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Progesterone is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids of uterine cancer. Progesterone, converted from pregnenolone, also serves as an intermediate in the biosynthesis of gonadal steroid hormones and adrenal corticosteroids. Progesterone is a naturally occurring steroid that is secreted by the ovary, placenta, and adrenal gland. In the presence of adequate estrogen, progesterone transforms a proliferative endometrium into a secretory endometrium. Progesterone is necessary to increase endometrial receptivity for implantation of an embryo. Once an embryo is implanted, progesterone acts to maintain a pregnancy. Progesterone shares the pharmacological actions of the progestins. Progesterone binds to the progesterone and estrogen receptors. Target cells include the female reproductive tract, the mammary gland, the hypothalamus, and the pituitary. Once bound to the receptor, progesterone will slow the frequency of release of gonadotropin releasing hormone (GnRH) from the hypothalamus and blunt the pre-ovulatory LH (luteinizing hormone) surge. In women who have adequate endogenous estrogen, progesterone transforms a proliferative endometrium into a secretory one. Progesterone is metabolized primarily by the liver largely to pregnanediols and pregnanolones. Pregnanediols and pregnanolones are conjugated in the liver to glucuronide and sulfate metabolites. Progesterone metabolites that are excreted in the bile may be deconjugated and may be further metabolized in the gut via reduction, dehydroxylation, and epimerization. Common progesterone side effects may include: drowsiness, dizziness; breast pain; mood changes; headache; constipation, diarrhea, heartburn; bloating, swelling in your hands or feet; joint pain; hot flashes; or vaginal discharge.
Status:
US Approved Rx
(2015)
Source:
ANDA203112
(2015)
Source URL:
First marketed in 1921
Source:
Quinine Dihydrochloride U.S.P.
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Quinine soluble salts possess the extremely bitter taste, that may have a perplexing problem especially to children. That is why the most common combinations which are administered in this way are the sulphate, salicylate, tannate and certain esters. Quinine tannate, an insoluble quinine salt has been known in medicine for a very long time. However, many experiments have revealed that quinine tannate was practically inert as a medicinal substance.
Status:
US Approved Rx
(2024)
Source:
ANDA215618
(2024)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Atropine inhibits the muscarinic actions of acetylcholine on structures innervated by postganglionic cholinergic nerves, and on smooth muscles which respond to endogenous acetylcholine but are not so innervated. As with other antimuscarinic agents, the major action of atropine is a competitive or surmountable antagonism which can be overcome by increasing the concentration of acetylcholine at receptor sites of the effector organ (e.g., by using anticholinesterase agents which inhibit the enzymatic destruction of acetylcholine). The receptors antagonized by atropine are the peripheral structures that are stimulated or inhibited by muscarine (i.e., exocrine glands and smooth and cardiac muscle). Responses to postganglionic cholinergic nerve stimulation also may be inhibited by atropine but this occurs less readily than with responses to injected (exogenous) choline esters. Atropine is relatively selective for muscarinic receptors. Its potency at nicotinic receptors is much lower, and actions at non-muscarinic receptors are generally undetectable clinically. Atropine does not distinguish among the M1, M2, and M3 subgroups of muscarinic receptors.
Status:
US Approved Rx
(1984)
Source:
ANDA088366
(1984)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
The ammonium cation is a positively charged polyatomic ion with the chemical formula NH4+. Ammonium ions are a waste product of the metabolism of animals. In fish and aquatic invertebrates, it is excreted directly into the water. In mammals, sharks, and amphibians, it is converted in the urea cycle to urea, because urea is less toxic and can be stored more efficiently. In birds, reptiles, and terrestrial snails, metabolic ammonium is converted into uric acid, which is solid and can therefore be excreted with minimal water loss. Ammonium is an important source of nitrogen for many plant species, especially those growing on hypoxic soils. However, it is also toxic to most crop species and is rarely applied as a sole nitrogen source. The ammonium ion (NH4+) in the body plays an important role in the maintenance of acid-base balance. The kidney uses ammonium (NH4+) in place of sodium (Na+) to combine with fixed anions in maintaining acid-base balance, especially as a homeostatic compensatory mechanism in metabolic acidosis. When a loss of hydrogen ions (H+) occurs and serum chloride (Cl–) decreases, sodium is made available for combination with bicarbonate (HCO3–). This creates an excess of sodium bicarbonate (NaHCO3) which leads to a rise in blood pH and a state of metabolic alkalosis. The therapeutic effects of Ammonium (as Ammonium Chloride) depend upon the ability of the kidney to utilize ammonia in the excretion of an excess of fixed anions and the conversion of ammonia to urea by the liver, thereby liberating hydrogen (H+) and chloride (Cl–) ions into the extracellular fluid.
Status:
US Approved Rx
(2023)
Source:
ANDA214950
(2023)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Since its discovery as component of the tea leaf by Albert Kossel in 1888, the history of theophylline (CAS 58-55-9) has been a long and successful one. At the turn of the century, theophylline became less expensive due to chemical synthesis and was primarily used as diuretic in subsequent years. It was Samuel Hirsch who discovered the bronchospasmolytic effect of theophylline in 1992, however, despite this pioneering discovery theophylline continued to be used primarily as diuretic and cardiac remedy. The molecular mechanism of bronchodilatation is inhibition of phosphodiesterase(PDE)3 and PDE4, but the anti-inflammatory effect may be due to histone deacetylase (HDAC) activation, resulting in switching off of activated inflammatory genes.
Theophylline is indicated for the treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.
Status:
US Approved Rx
(2015)
Source:
ANDA078830
(2015)
Source URL:
First marketed in 1899
Class (Stereo):
CHEMICAL (ABSOLUTE)
The alkaloid L-(-)-scopolamine [L-(-)-hyoscine], a belladonna alkaloid, competitively inhibits muscarinic receptors for acetylcholine and acts as a nonselective muscarinic antagonist, producing both peripheral antimuscarinic properties and central sedative, antiemetic, and amnestic effects. Scopolamine acts: i) as a competitive inhibitor at postganglionic muscarinic receptor sites of the parasympathetic nervous system, and ii) on smooth muscles that respond to acetylcholine but lack cholinergic innervation. It has been suggested that scopolamine acts in the central nervous system (CNS) by blocking cholinergic transmission from the vestibular nuclei to higher centers in the CNS and from the reticular formation to the vomiting center. Scopolamine can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate, and depress motor function. Scopolamine is used for premedication in anesthesia and for the prevention of nausea and vomiting (post operative and associated with motion sickness).
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 OTC
Source:
21 CFR 358.310 ingrown toenail sodium sulfide (aqueous)
Source URL:
First approved in 2003
Source:
21 CFR 358D
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
A sulfide ion is composed of a lone sulfur atom. Its charge is negative two, giving sulfides this formula: S^2-. Sulfide is a strong base, so solutions of sulfide in water are basic, due to hydrolysis. One well-known ionic compound with a sulfide ion is H_2S. The infamous rotten-egg smell often associated with sulfur originates from this compound. Sodium sulfide nonahydrate is used in the formation of surface functionalized cadmium sulfide quantum dots.
Status:
US Approved OTC
Source:
21 CFR 347.10(a) skin protectant allantoin
Source URL:
First approved in 1961
Source:
ALLANTOMIDE ALLANTOIN by NATIONAL DRUG
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
The aluminum salt of Allantoin, Alcloxa combines the astringent and anti-microbial properties of aluminum with the anti-irritant, soothing and healing properties of Allantoin. Alcloxa is particularly suited for use in anti-perspirants, acne treatments and foot care products. Alcloxa is a compound that combine the properties of aluminum salts with the properties of allantion. The allantion component ehhances the action of the aluminum salts and serves to overcome irritations experienced by many individuals who may be sensitive to the use of aluminum alts. The aluminum component reduces sweat by causing the sweat gland ducts swell. Alcloxa also add to the antiperspirant properties the deodorant effect because of its bacteriostatic action. It showed bacteriostatic properties at concentrations of 0.2% particularly against Gram bectaria (B. subtilis, S. aureus, P. vulgaris, Pityrosporum ovale). This is ascribable to two different mechanisms: first bacterial growth is retarded due to a decrease in the amount of water present, second aluminum salt have itself an antimicrobial action. In baby products is indicated for its healing reparative action, in the treatment of diaper rash. Also is approved in haemorrhoidal product for its soothing and keratolytic action. In oral care products Alcloxa is useful for its astringent antibacterial properties. It is very indicated in formulations for sensitive teeth, periodontal and gum diseases (like gingivitis, irritable and bleeding gums). Use levels: 0.1-1%. − In antiacne products the slightly astringent effect promotes healing of pustules and acne lesions. It reduces the extension of infected skin eruptions, healing them and developing a soothing action. May be used alone or also in combinations with other antimicrobial agents in order to fight acne more effectively. Use levels: 0.5-2.0%.
Status:
US Approved OTC
Source:
21 CFR 341.12(d) cough/cold:antihistamine dexbromopheniramine maleate
Source URL:
First approved in 1959
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
DEXBROMPHENIRAMINE is an alkylamine derivative with anticholinergic and sedative properties. It is a histamine H1-receptor antagonist that competes with histamine for the H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract. The antagonistic action of this agent blocks the activities of endogenous histamine, which subsequently leads to temporary relief from the negative histamine-mediated symptoms of an allergic reaction such as bronchoconstriction, vasodilation, increased capillary permeability and spasmodic contractions of the gastrointestinal smooth muscle. DEXBROMPHENIRAMINE as a part of combination medicine is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.