U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

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Showing 141 - 150 of 457 results

Status:
Other

Class (Stereo):
CHEMICAL (ABSOLUTE)

Gemifloxacin is an oral broad-spectrum quinolone antibacterial agent used in the treatment of acute bacterial exacerbation of chronic bronchitis and mild-to-moderate pneumonia. Gemifloxacin mesylate is marketed under the brand name Factive, indicated for the treatment of bacterial infection caused by susceptible strains such as S. pneumoniae, H. influenzae, H. parainfluenzae, or M. catarrhalis, S. pneumoniae (including multi-drug resistant strains [MDRSP]), M. pneumoniae, C. pneumoniae, or K. pneumoniae. Gemifloxacin has in vitro activity against a wide range of Gram-negative and Grampositive microorganisms. Gemifloxacin is bactericidal with minimum bactericidal concentrations (MBCs) generally within one dilution of the minimum inhibitory concentrations (MICs). Gemifloxacin acts by inhibiting DNA synthesis through the inhibition of both DNA gyrase and topoisomerase IV (TOPO IV), which are essential for bacterial growth. Streptococcus pneumoniae showing mutations in both DNA gyrase and TOPO IV (double mutants) are resistant to most fluoroquinolones. Gemifloxacin has the ability to inhibit both enzyme systems at therapeutically relevant drug levels in S. pneumoniae (dual targeting), and has MIC values that are still in the susceptible range for some of these double mutants.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(vi)(B) skin protectant:poison ivy/oak/sumac w/ sales less than $25,000 isopropyl palmitate
Source URL:
First approved in 1996
Source:
Hydrocortisone Acetate Pramoxine Hcl by Bryant Ranch Prepack
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)


Conditions:

Isopropyl palmitate is the ester of isopropyl alcohol and palmitic acid. It is an emollient, moisturizer, thickening agent, and anti-static agent. Isopropyl Palmitate is a traditional, fast spreading emollient for modern cosmetic applications. Isopropyl palmitate is approved by ECOCERT for Natural and Organic Cosmetics. It is on FDA CFR - Code of Federal Regulations Title 21 list.
Status:
US Previously Marketed
Source:
EXOSURF NEONATAL by GLAXOSMITHKLINE
(1990)
Source URL:
First approved in 1990

Class (Stereo):
CHEMICAL (ABSOLUTE)


Colfosceril palmitate (dipalmitoylphosphatidylcholine) is a synthetic pulmonary surfactant, which is used in infants with respiratory distress syndrome it was approved in 1990, but nowadays it is under the state of canceled post-marketing. Colfosceril palmitate is reducing the tension and stabilizing the alveoli from collapsing.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(iv) skin protectant:fever blister/cold sore trolamine
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)


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:
Possibly Marketed Outside US
First approved in 2023

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)

Showing 141 - 150 of 457 results