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Status:
Possibly Marketed Outside US
Source:
21 CFR 347
(2012)
Source URL:
First approved in 1977
Source:
NDA017563
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Maltol is a naturally occurring organic compound isolated from pine needles, larch bark, the destructive distillates of various organic materials and the alkaline hydrolysis products of streptomycin. Because of caramel-butterscotch odor, and suggestive of fruity-strawberry aroma in dilute solutions, maltol is used as a food additive mainly in confectionary and bakery products. Maltol is considered safe by FDA according to existing data and granted GRAS status. Maltol chelates metal ions such as Fe3+, Al3+, and is reported to increase uptake of aluminum and iron in the body. Maltol was reported to have a neuroprotective effect on retinal ganglion cells under oxidative stress, and hepatoprotective effect on alcohol-induced liver oxidative injury.
Status:
Possibly Marketed Outside US
Source:
21 CFR 334
Source URL:
First approved in 1977
Source:
K PhosNeutral by Beach Products, Inc.
Source URL:
Class:
MIXTURE
Status:
US Approved Rx
(1977)
First approved in 1977
Class:
POLYMER
Status:
US Approved Rx
(1977)
First approved in 1977
Class:
POLYMER
Status:
US Approved Rx
(1977)
First approved in 1977
Class:
POLYMER
Status:
US Approved Rx
(2024)
Source:
ANDA217667
(2024)
Source URL:
First approved in 1977
Class:
POLYMER
Tetraethylenepentamine (TEPA) is a low-molecular-weight linear polyamine exerting metal-chelating properties. TEPA is widely used in industrial applications. The principal hazards that arise in working with TEPA are those associated with similar organic amines; namely, a corrosive action on skin and eyes. TEPA biological activity was attributed to its effect on cellular Cu levels as (a) treatment with TEPA resulted in reduction of cellular Cu, and (b) excess of Cu reversed TEPA's activity and accelerated differentiation. TEPA was shown to attenuate the differentiation of ex vivo cultured hematopoietic cells resulting in preferential expansion of early progenitors. A phase I/II trial was performed to test the feasibility and safety of transplantation of CD133+ cord blood (CB) hematopoietic progenitors cultured in media containing stem cell factor, FLT-3 ligand, interleukin-6, thrombopoietin and TEPA. Transplanting a population of CD133+ CB cells which were expanded ex vivo for 21 days using SCF, FLT3, IL-6, TPO and the copper chelator TEPA (StemEx) was feasible. The expanded cells were well tolerated, with no infusion-related adverse events observed.
Status:
US Approved Rx
(1977)
First approved in 1977
Class:
POLYMER
Status:
US Approved Rx
(1977)
First approved in 1977
Class:
POLYMER
Status:
US Approved Rx
(1977)
First approved in 1977
Class:
POLYMER
Status:
US Approved Rx
(1977)
First approved in 1977
Class:
POLYMER