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Restrict the search for
chloramphenicol palmitate
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:
CHLOROMYCETIN HYDROCORTISONE by PARKEDALE
(1953)
Source URL:
First approved in 1950
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Chloramphenicol is a broad-spectrum antibiotic that was first isolated from
Streptomyces venezuelae in 1947. The drug was subsequently chemically synthesized. It has both a bacteriostatic and bactericidal effect; in the usual therapeutic concentrations it is bacteriostatic. Chloramphenicol is used for the treatment of serious gram-negative, gram-positive, and anaerobic infections. It is especially useful in the treatment of meningitis, typhoid fever, and cystic fibrosis. It should be reserved for infections for which other drugs are ineffective or contraindicated. Chloramphenicol, a small inhibitor of bacterial protein synthesis, is active against a variety of bacteria and readily enters the CSF. It has been used extensively in the last decades for the treatment of bacterial meningitis. In industrialized countries, chloramphenicol is restricted mostly to topical uses because of the risk of induction of aplastic anemia. However, it remains a valuable reserve antibiotic for patients with allergy to β-lactam antibiotics or with CNS infections caused by multiresistant pathogens.
Status:
Possibly Marketed Outside US
Source:
M015
(2023)
Source URL:
First approved in 2023
Source:
M015
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Status:
Possibly Marketed Outside US
Source:
Ascuoli by HEALGROW INC
(2023)
Source URL:
First approved in 2023
Source:
Ascuoli by HEALGROW INC
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
M006
(2022)
Source URL:
First approved in 2022
Source:
M006
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2019)
Source URL:
First approved in 2019
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
Biellee Pollen Hydra Pure Brightening Cream by NSB CO., LTD.
(2016)
Source URL:
First approved in 2016
Source:
Biellee Pollen Hydra Pure Brightening Cream by NSB CO., LTD.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 333D
(2015)
Source URL:
First approved in 2015
Source:
21 CFR 333D
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2015)
Source URL:
First approved in 2015
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Status:
Possibly Marketed Outside US
Source:
21 CFR 347
(2015)
Source URL:
First approved in 2015
Source:
21 CFR 347
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
