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Restrict the search for
fludarabine phosphate
to a specific field?
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(v)(A) skin protectant:insect bites/stings trolamine
Source URL:
First approved in 1952
Source:
NDA007936
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Trolamine, an organic compound, is the salt formed between triethanolamine and salicylic acid. It is widely used as a topical analgesic. 10% trolamine salicylate medical products sold over-the-counter such as are creams for temporarily relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, lumbago, neuralgia, strains, bruises, and sprains. The FDA approved in 1958 otic solution drops containing triethanolamine polypeptide used in the ear to break down and loosen earwax was discontinued. Trolamine can enhance skin healing by recruiting macrophages and modifying the concentrations of various immunomodulators. Trolamine (Biafine; Genmedix Ltd, France) is commonly prescribed at the beginning of radiotherapy for preventing acute radiation-induced skin toxicity in China. Biafine has been studied in radiodermatitis and Phase 2 clinical trial has been initiated in 2016 by Sun Yat-sen University to establish the efficacy of trolamine (Biafine) for the management of radiation dermatitis in patients with nasopharyngeal carcinoma receiving IMRT.
Status:
US Previously Marketed
Source:
CO-PYRONIL PYRROBUTAMINE NAPHTHALENE DISULFONATE by DISTA PRODUCTS
(1961)
Source URL:
First approved in 1952
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
PYRROBUTAMINE is a potent H1-antihistamine. H1-antihistamines interfere with the agonist action of histamine at the H1 receptor and are administered to attenuate the inflammatory process in order to treat conditions such as allergic rhinitis, allergic conjunctivitis, and urticaria.
Status:
US Previously Marketed
Source:
PAVERIL PHOSPHATE by LILLY
(1961)
Source URL:
First approved in 1951
Class (Stereo):
CHEMICAL (ACHIRAL)
Dimoxyline is the synthetic analogue of papaverine, Acute toxicity studies show it to be less toxic than papaverine. No analgesic action and no tolerance development in experimental animals by repeated administration. But Dimoxyline does not appear to be as potent as papaverine in comparable dosage. Dimoxyline is indicated for the treatment of patients with angina pectoris. Also, significant amount of benefit was claimed in patients with acute or chronic phlebitis, arterial thrombosis or embolism, Raynaud’s phenomena and early thromboangiitis obliterans or arteriosclerosis obliterans. Detected adverse events are: nausea or abdominal cramps.
Status:
US Previously Marketed
Source:
GANTRISIN by ROCHE
(1982)
Source URL:
First approved in 1949
Source:
GANTRISIN by ROCHE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Diethanolamine (DEA) is an amino alcohol commonly used in the preparation of soaps and surfactants, agricultural chemicals and in textile processing. DEA and DEA-Derivatives are used in other products besides cosmetics and personal care products. For example, DEA and DEA-derivatives have been approved for several food-related applications, primarily food packaging.
Status:
First approved in 1949
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Adenosine monophosphate (AMP) is a nucleotide, consisting of a phosphate group, the sugar ribose, and the nucleobase adenine. AMP is an activator of several enzymes in the tissues. In the glycolytic pathway, the enzyme phosphofructokinase is inhibited by ATP but the inhibition is reversed by AMP, the deciding factor for the reaction being the ratio between ATP and AMP. In medicine, AMP is used mainly as an alternative to adenosine for treatment of ischemia and as a tool compound to measure hyperresponsiveness of airways.
Status:
US Previously Marketed
First approved in 1948
Class (Stereo):
CHEMICAL (ACHIRAL)
Pentaquine is an 8-aminoquinoline that was used in the 1950s to treat malaria and trypanosomiasis. Pentaquine showed no significant sporontocidal activity against P. gallinaceum in Aedes aegypti. In the experimental animals, the antimalarial effect of pentaquine, its pharmacology and toxicology have been investigated (1, 2). Activity, 80 to 128 times that of quinine and two to eight times that of pamaquin in avian malaria. It has adverse effects very similar to those of primaquine. In mammals it is rapidly absorbed from the gastro-intestinal tract. In acute, and in short term chronic toxicity studies, pentaquine was from one-fourth to one-half as toxic as pamaquin. In the dog, pamaquin in large doses produces severe anorexia, emaciation and ocular paralysis due to central impairment of the sympathetic innervation of the eye. In high dosages pamaquin produces leukopenia, neutropenia, anemia, methemoglobinemia, emaciation, depression, and liver damage in the monkey, effects which are not produced with pentaquine in this species.
Status:
US Previously Marketed
Source:
VASOCON-A by NOVARTIS
(1990)
Source URL:
First approved in 1948
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Antazoline is an antagonist of histamine H1 receptors. It selectively bind to but does not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine, which subsequently leads to temporary relief of the negative symptoms brought on by histamine. Antazoline in combination with naphazoline (VASOCON-A®) is indicated to relieve the symptoms of allergic conjunctivitis.
Status:
US Previously Marketed
First approved in 1946
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Octodrine is a stimulant that is structurally similar to amphetamine and is included in several so-called “pre-workout” and “fat-burning” supplements. Octodrine, has a history of use as a pharmaceutical drug. It was originally developed in the United States as an aerosolized treatment for bronchitis, laryngitis and other conditions Initially approved by the FDA in 1946 as Eskay’s Oralator, this inhaler appeared only in the 1949 edition of the Physicians’ Desk Reference. Octodrine was combined with several other medications, including theophylline, 3-octopamine, and adenosine, in multi-ingredient tablets sold between the early 1960s through the mid-2000s under the trade names Ambredin, Ordinal, Ordinal Retard and Ordinal Forte. Some proponents say octodrine is a safer alternative to other stimulants like ephedra and Dimethylamylamine (DMAA), but there is no scientific information to support this claim. Originally developed in the early 1950’s as a remedy to nasal congestion and as a possible anti-tumor drug, Octodrine has resurfaced as a key ingredient in dietary supplements for its stimulant and thermogenic benefits.
Status:
US Previously Marketed
Source:
DIETHYLSTILBESTROL by LILLY
(1982)
Source URL:
First approved in 1941
Source:
STILBESTROL by BRISTOL MYERS SQUIBB
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Diethylstilbestrol is a synthetic non-steroidal estrogen. It is used in the treatment of menopausal and postmenopausal disorders, prostate cancer and in the prevention of miscarriage or premature delivery in pregnant women prone to miscarriage or premature delivery. Diethylstilbestrol is a very potent full agonist of the estrogen receptors. At the cellular level, estrogens increase the synthesis of DNA, RNA, and various proteins in target tissues. Pituitary mass is also increased. Estrogens reduce the release of gonadotropin-releasing hormone from the hypothalamus, leading to a reduction in release of follicle-stimulating hormone and luteinizing hormone from the pituitary. Adverse effects are: breast pain or tenderness, enlargement of breasts, gynecomastia, peripheral edema and others. Estrogens may interfere with the effects of bromocriptine. Dosage adjustment may be needed. Concurrent use with estrogens may alter the metabolism and protein binding of the glucocorticoids, leading to decreased clearance, increased elimination half-life, and increased therapeutic and toxic effects of the glucocorticoids.
Status:
US Previously Marketed
Source:
Dinitrophenol
(1933)
Source URL:
First marketed in 1933
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
2,4-dinitrophenol (DNP) is a FDA-banned weight-loss agent and EPA-regulated environmental toxicant, traditionally used in research labs as an uncoupler of OXPHOS. Although not licensed for human consumption, DNP and DNP crystal form are used by bodybuilders and extreme dieters for their fat burning properties through inhibiting efficient energy (ATP) production in cells. Through uncoupling mitochondrial oxidative phosphorylation by facilitating proton transport across the mitochondrial membrane, DNP leads to rapid consumption of energy without generating ATP and consequently, to increased fat metabolism. However, the weight-loss effect comes with serious, and in some cases potentially fatal, adverse side effects, namely hyperthermia (the leading cause of fatality with acute DNP toxicity) and cardiac arrest, but also diaphoresis, tachycardia, tachypnea, skin toxicity, Fourier’s gangrene and cataracts with low dose chronic exposure. The proposed mechanism of DNP induced toxicity suggests the activation of ATP-sensitive K channels.
