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Search results for m root_references_citation in Reference Text / Citation (approximate match)
Status:
US Approved Allergenic Extract
Source:
BLA103888
Source URL:
First approved in 1941
Source:
BLA103888
Source URL:
Class:
MIXTURE
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(24)(i) menstrual/diuretic aloes
Source URL:
First approved in 1976
Source:
Benzoin by James Alexander Corporation
Source URL:
Class:
MIXTURE
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(20) weight control plantago seed
Source URL:
First approved in 1949
Source:
Hydrocil Instant Dietary Fiber Supplement by NUMARK BRANDS, INC
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
BLA125614
(2017)
Source URL:
First approved in 2017
Source:
BLA125614
Source URL:
Class:
MIXTURE
QS-21 is a purified soapbark tree (Quillaja saponaria) extract that enhances the ability of the immune system to respond to vaccine antigens. QS-21 is a promising adjuvant candidate for use in humans due to the ease of purification, its improved safety profile, and its ability to enhance cellular and humoral immunogenicity. The mechanism of action of QS-21 was speculated to be similar to QA, forming complexes with cholesterol that intercalate into the cell membrane lipids. This intercalation creates pores in the membrane to accelerate the uptake of a co-delivered antigen by the antigen presenting cells. Multiple clinical trials using QS-21 as an adjuvant, demonstrated satisfactory safety profiles and enhanced immunogenicity in immunocompromised volunteers
Status:
Possibly Marketed Outside US
Source:
BLA125614
(2017)
Source URL:
First approved in 2017
Source:
BLA125614
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
Octaplasma by Octapharma Pharmazeutika Produktionsges M B H [Canada]
Source URL:
First approved in 2013
Source:
BLA125416
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
Ethical Herbals Natural Pain Reliever by Ashbury Research Corporation [Canada]
Source URL:
First approved in 2010
Source:
21 CFR 333D
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
21 CFR 333C
(2023)
Source URL:
First approved in 1968
Source:
NDA204426
Source URL:
Class:
MIXTURE
Status:
US Approved Rx
(2015)
Source:
BLA761036
(2015)
Source URL:
First approved in 2015
Source:
BLA761036
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2010)
Source:
BLA125320
(2010)
Source URL:
First approved in 2010
Source:
BLA125320
Source URL:
Class:
PROTEIN
