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Search results for "JECFA|Functional Classification|Emulsifier" in comments (approximate match)
Status:
US Approved OTC
Source:
21 CFR 349.12(d)(4) ophthalmic:demulcents polysorbate 80
Source URL:
First approved in 1949
Class:
POLYMER
Conditions:
Polysorbate 80 is a nonionic surfactant and emulsifier often used in foods and cosmetics. Polysorbate 80 is an excipient that is used to stabilize aqueous formulations of medications for parenteral administration, and used as an emulsifier in the manufacture of the popular antiarrhythmic amiodarone. Polysorbate 80 is also used as an excipient in some European and Canadian influenza vaccines. Influenza vaccines contain 25 μg of polysorbate 80 per dose. Polysorbate 80 is also used in the culture of Mycobacterium tuberculosis in Middlebrook 7H9 broth. It is also used as an emulsifier in the estrogen-regulating drug Estrasorb. In Europe and America, people eat about 100 mg of polysorbate 80 in foods per day on average. Polysorbate 80 has not been found to be carcinogenic. Rats fed with diets containing up to 5% polysorbate 80 by volume for 12 weeks showed no toxic effects.
Status:
Investigational
Source:
NCT03358810: Not Applicable Interventional Completed Dysphagia Following Cerebral Infarction
(2018)
Source URL:
Class:
POLYMER
Status:
Other
Class:
POLYMER
Status:
US Previously Marketed
Source:
21 CFR 310.527(a) hair loss prevention polysorbate 20
Source URL:
First approved in 1978
Source:
60-Second Fluoride Pina Colada by Patterson Dental Supply Inc
Source URL:
Class:
POLYMER
Status:
US Previously Marketed
First approved in 1957
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
ANDA203695
(2017)
Source URL:
First approved in 2017
Source:
ANDA203695
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
ANDA065078
(2005)
Source URL:
First approved in 2005
Source:
ANDA065078
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
ANDA076477
(1996)
Source URL:
First approved in 1996
Source:
ANDA076477
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
21 CFR 333E
(2020)
Source URL:
First approved in 1995
Source:
21 CFR 350
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
21 CFR 348
(2001)
Source URL:
First approved in 1953
Source:
NDA008762
Source URL:
Class:
POLYMER
