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Restrict the search for
benzoyl peroxide
to a specific field?
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:
US Approved Rx
(2015)
Source:
ANDA202765
(2015)
Source URL:
First approved in 1958
Source:
NDA011210
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Benzonatate is an antitussive that is FDA approved for the symptomatic relief of cough. It acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough reflex at its source. Common adverse reactions include nausea, oral hypoesthesia, throat symptom, numbness, dizziness, headache, sedation, somnolence. Benzonatate is chemically related to anesthetic agents of the para-amino-benzoic acid class (e.g. procaine; tetracaine) and has been associated with adverse CNS effects possibly related to a prior sensitivity to related agents or interaction with concomitant medication.
Status:
US Approved Rx
(2007)
Source:
ANDA040767
(2007)
Source URL:
First approved in 1953
Source:
METHOTREXATE SODIUM by STRIDES PHARMA
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Methotrexate is an antineoplastic anti-metabolite. Anti-metabolites masquerade as purine or pyrimidine - which become the building blocks of DNA. They prevent these substances becoming incorporated in to DNA during the "S" phase (of the cell cycle), stopping normal development and division. Methotrexate inhibits folic acid reductase which is responsible for the conversion of folic acid to tetrahydrofolic acid. At two stages in the biosynthesis of purines and at one stage in the synthesis of pyrimidines, one-carbon transfer reactions occur which require specific coenzymes synthesized in the cell from tetrahydrofolic acid. Tetrahydrofolic acid itself is synthesized in the cell from folic acid with the help of an enzyme, folic acid reductase. Methotrexate looks a lot like folic acid to the enzyme, so it binds to it quite strongly and inhibits the enzyme. Thus, DNA synthesis cannot proceed because the coenzymes needed for one-carbon transfer reactions are not produced from tetrahydrofolic acid because there is no tetrahydrofolic acid. Methotrexate selectively affects the most rapidly dividing cells (neoplastic and psoriatic cells). Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. In acute lymphocytic leukemia, methotrexate is indicated in the prophylaxis of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents. Methotrexate is also indicated in the treatment of meningeal leukemia. Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma), and lung cancer, particularly squamous cell and small cell types. Methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-Hodgkin’s lymphomas. Methotrexate is indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis. Methotrexate is indicated in the management of selected adults with severe, active rheumatoid arthritis (ACR criteria), or children with active polyarticular-course juvenile rheumatoid arthritis.
Status:
US Approved Rx
(2000)
Source:
ANDA040335
(2000)
Source URL:
First approved in 1952
Source:
LEUCOVORIN CALCIUM by HOSPIRA
Source URL:
Class (Stereo):
CHEMICAL (EPIMERIC)
Leucovorin is a compound similar to folic acid, which is a necessary vitamin. It has been around and in use for many decades. Leucovorin is a medication frequently used in combination with the chemotherapy drugs fluoruracil and methotrexate. Leucovorin is not a chemotherapy drug itself, however it is used in addition to these chemotherapy drugs to enhance anticancer effects (with fluorouracil) or to help prevent or lessen side effects (with methotrexate). Leucovorin is also used by itself to treat certain anemia problems when folic acid deficiency is present.
Status:
US Approved Rx
(2018)
Source:
NDA211226
(2018)
Source URL:
First approved in 1952
Source:
NDA020140
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Levoleucovorin is the pharmacologically active isomer of leucovorin or 5-formyl tetrahydrofolic acid, a folate analog . Levoleucovorin does not require reduction by the enzyme dihydrofolate reductase in order to participate in reactions utilizing folates as a source of “onecarbon” moieties. Administration of levoleucovorin can counteract the therapeutic and toxic effects of folic acid antagonists such as methotrexate, which act by inhibiting dihydrofolate reductase. Levoleucovorin can enhance the therapeutic and toxic effects of fluoropyrimidines used in cancer therapy such as 5-fluorouracil. 5-fluorouracil is metabolized to 5-fluoro-2'-deoxyuridine-5'-monophosphate (FdUMP), which binds to and inhibits thymidylate synthase (an enzyme important in DNA repair and replication). Levoleucovorin is readily converted to another reduced folate, 5,10-methylenetetrahydrofolate, which acts to stabilize the binding of FdUMP to thymidylate synthase and thereby enhances the inhibition of this enzyme. Fusilev® (levoleucovorin) is approved by FDA for i) rescue after high-dose methotrexate therapy in osteosarcoma, ii) diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists and iii) in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.
Status:
US Approved Rx
(2001)
Source:
NDA021265
(2001)
Source URL:
First approved in 1946
Source:
FOLVRON by LEDERLE
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Folic Acid is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para-aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of Folic Acid are present in a wide variety of foods, particularly liver, kidneys, yeast and leafy green vegetables. Commercially available Folic Acid is prepared synthetically. Folic Acid occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Aqueous solutions of Folic Acid are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light. Folic Acid is effective in the treatment of megaloblastic anemias due to a deficiency of Folic Acid (as may be seen in tropical or nontropical sprue) and in anemia of nutritional origin, pregnancy, infancy, or childhood. Folic Acid is relatively nontoxic in man. Rare instances of allergic responses to Folic Acid preparations have been reported and have included erythema, skin rash, itching, general malaise, and respiratory difficulty due to bronchospasm. Endocyte is developing an intravenous (IV) formulation of folic acid, called Neocepri®, which is intended for the diagnosis of positive folate receptor-positive status in patients with ovarian cancer when administered prior to the radioactive medicine, technetium Tc99m Etarfolatide. The benefits of Neocepri® are its ability to reduce the background activity observed on single photon emission computed tomography (SPECT) imaging in most normal, nontarget tissues (e.g. intestines, liver, kidney, spleen), thereby improving the image quality of the scans. The product had been granted orphan drug designation in the EU. Endocyte had filed a conditional marketing authorization application (CMA) with the European Medicines Agency (EMA) for Neocepri®.
Status:
US Approved Rx
(2016)
Source:
ANDA205880
(2016)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Benzoic acid is a natural ingredient occurring in many foodstuffs and in plant extracts. Benzoic acid, its salts and esters are used as preservatives in cosmetic products, with a maximum concentration of 0.5 %. Benzoic acid and sodium benzoate are on the FDA list of substances that are generally recognized as safe (GRAS). Both may be used as antimicrobial agents, flavouring agents and as adjuvants with a current maximum level of 0.1% in food. Benzoic acid is a constituent of Whitfield Ointment, which is used for the treatment of fungal skin diseases such as tinea, ringworm, and athlete's foot. Adverse effect of Whitfield Ointment: occasionally, a localized mild inflammatory response occurs.
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 346.18(a) anorectal:astringent calamine
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
There is no available information related any biological and pharmaceutical application of ammonium tetrachlorozincate.
Status:
US Approved OTC
Source:
21 CFR 344.1 otic:earwax removal aid carbamide peroxide 6.5% (in anhydrous glycerin)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Hydrogen peroxide has been used in medicine for more than 100 years. It is known in surgery as a highly useful irrigation solution by virtue of both its hemostatic and its antimicrobial effects. Hydrogen peroxide is a mild antiseptic used on the skin to prevent infection of minor cuts, scrapes, and burns. It may also be used as a mouth rinse to help remove mucus or to relieve minor mouth irritation (e.g., due to canker/cold sores, gingivitis). This product works by releasing oxygen when it is applied to the affected area. The release of oxygen causes foaming, which helps to remove dead skin and clean the area. Hydrogen peroxide is a strong oxidizing agent used in aqueous solution as a ripening agent, bleach, and topical anti-infective. It is relatively unstable and solutions deteriorate over time unless stabilized by the addition of acetanilide or similar organic materials.
