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Status:
Possibly Marketed Outside US
Source:
NDA019600
(1986)
Source URL:
First approved in 1986
Source:
NDA019600
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
1,4-Sorbitan is a sorbitol anhydration product. 1,4-Sorbitan is a precursor to environmentally benign surfactants. It is a component of Sorbitol-Sorbitan mixtures used as soft gel plasticizers. They enhance the soft gelatin capsule finish gloss for a premium appearance, help to prevent leakage, provide consistent pharmaceutical quality, and extend shelf life by maintaining a proper moisture balance within the capsule shell.
Status:
Possibly Marketed Outside US
Source:
21 CFR 333E
(2002)
Source URL:
First approved in 1985
Source:
ANDA078854
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
First approved in 1985
Source:
Paraguard by Seachem Laboratories Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Malachite green, an N-methylated diaminotriphenylmethane dye, is used primarily as a therapeutic agent in aquaculture. It controls fungal attacks, protozoan infections and some other diseases caused by helminths on a wide variety of fish and other aquatic organisms. In solution, the dye exists as a mixture of the cation (chromatic malachite green) and its carbinol base, with the ratio depending on the pH of the solution; the dye also can undergo chemical and metabolic reduction to a leuco derivative. Malachite green intercalates with DNA, with a preference for A:T-rich regions, and the leuco derivative bears a structural resemblance to carcinogenic aromatic amines that can form covalent DNA adducts. In mammalian cells, it shows marked cytotoxicity and the ability to induce cell transformation and lipid peroxidation. The toxicity of this dye increases with exposure time, temperature and concentration. It has been reported to cause carcinogenesis, mutagenesis, chromosomal fractures, teratogenecity and respiratory toxicity.
Status:
Possibly Marketed Outside US
Source:
ANDA088389
(1985)
Source URL:
First approved in 1985
Source:
ANDA088389
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Potassium bisulfite is a chemical compound with the chemical formula KHSO3. Potassium bisulphite is used for the preservation of colourless food materials such as fruit juices, squashes, apples and raw mango chutney. Potassium bisulfite solutions are used in a variety of different applications, including use as a food preservative (E228) to prevent spoilage and discoloration, as a preservative for pharmaceuticals (nebulizer solutions, parenterals, peritoneal dialysis solutions). It is also an antiseptic and sulfurous acid source, especially in brewing. Potassium bisulfite also functions as hair-waving/straightening agent. Potassium bisulfite is generally recognized as safe by FDA when used in accordance with good manufacturing or feeding practice, except that it is not used in meats or in food recognized as source of vitamin B1.
Status:
Possibly Marketed Outside US
First approved in 1985
Source:
Paraguard by Seachem Laboratories Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Glutaraldehyde is marketed by The Dow Chemical Company under several trade names in a wide range of applications from leather tanning, photography, paper, water treatment, and high level disinfection of medical instrumentation to animal husbandry. Biocide, glutaraldehyde, is widely used in products for disinfection, sanitisation, preservation and slimicidal application in industry, hospitals and on farms. Products based on glutaraldehyde are effective against Gram positive and Gram negative bacteria, fungi, and a variety of viruses (including infectious bursal disease, porcine reproductive and respiratory syndrome virus, hog cholera virus, human corona virus. Glutaraldehyde is toxic and a strong irritant
Status:
Possibly Marketed Outside US
Source:
NDA213150
(1985)
Source URL:
First approved in 1985
Source:
NDA213150
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Methyl pyrrolidone (or N-methyl pyrrolidone or NMP) is a small molecule acetyl‐lysine mimetic compound with potent immunomodulatory and direct anti‐myeloma activity. NMP is nontoxic, stable and already in use as a solvent in biomedical applications. This compound is under investigation in clinical trial phase I for the treatment of multiple myeloma. The study will evaluate if the NMP can be safely administered to humans at doses, which induce measurable immunological and anti-tumor effects in patients with myeloma. In addition, NMP could be useful for bone fracture repairing. NMP has shown a protective role in osteoblast differentiation in response to hypoxia, and such protection was through inhibiting the NF-κB signaling. Experiments on rodents have revealed that the compound had a remarkable anti-osteoporotic ability preserving activity in the pulp-dentine complex and preventing jawbone loss. These effects made NMP a promising candidate for the preservation of the activity of the pulp-dentin complex and jawbone thickness in post-menopausal females.
Status:
Possibly Marketed Outside US
Source:
ANDA086996
(1985)
Source URL:
First approved in 1985
Source:
ANDA086996
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
TRIMYRISTIN is an inactive component of RODAN AND FIELDS ENHANCEMENTS used to prevent sunburns. TRIMYRISTIN is a constituent of nutmegs.
Status:
Possibly Marketed Outside US
Source:
PLIAGLIS by Atlas Powder
Source URL:
First approved in 1985
Source:
ANDA088450
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Sorbitan monopalmitate (Span 40) is a nonionic emulsifier, surfactant and food additive. The product of Croda Inc. Span 40 is used in skin care, hair care and decorative cosmetics. It is also used as an effector in compositions capable of facilitating penetration across a biological barrier. Inactive ingredient of some medications it improves transdermal delivery of drugs and is a potential carrier for topical drug delivery. In PLIAGLIS cream (lidocaine and tetracaine) sorbitan monopalmitate is used as an inactive ingredient. Sorbitan monopalmitate is a fatty acid sorbitan ester, yellowish brown wax, slightly soluble in isopropanol, xylene and liquid paraffin, insoluble in water, non-toxic.
Status:
Possibly Marketed Outside US
Source:
M003
(2022)
Source URL:
First approved in 1985
Source:
NDA207768
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Ethyl maltol, a key food additive, and flavor enhancer is safe and is the most common sweet-associated component in electronic cigarette liquids. Ethyl maltol binds to human serum albumin (HSA) by situating within subdomain IIA (site I) of HSA.
Status:
Possibly Marketed Outside US
Source:
ANDA209351
(1984)
Source URL:
First approved in 1984
Source:
ANDA209351
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)