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Status:
Possibly Marketed Outside US
Source:
Dermaheal Cosmeceutical Mask Pack Plus by YBK Investment, INC
Source URL:
First approved in 2012
Source:
21 CFR 347
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2012)
Source:
NDA202292
(2012)
Source URL:
First approved in 2012
Source:
NDA202292
Source URL:
Class:
POLYMER
Conditions:
Crofelemer, previously known as the investigational drug SP-303, is a novel proanthocyanidin purified from the bark latex of the Amazonian Croton tree Croton lechleri. It is marketed under the brand name Fulyzaq and indicated for the symptomatic treatment of non-infectious diarrhea in adult patients with HIV/AIDS who are taking antiretroviral therapy. Fulyzaq treats the symptoms of disease, but it is not used to treat infectious diarrhea (diarrhea caused by infection of the digestive system by a bacteria, virus or parasite). It was initially developed by Napo Pharmaceuticals, which licensed it to Glenmark Pharmaceuticals in 140 emerging markets and to Salix Pharmaceuticals in the US, EU and some other markets. A Phase III clinical trial for diarrhoea in HIV patients was completed in 2012, and the drug was approved by the US Food and Drug Administration (FDA) on 31 December 2012.
Status:
Possibly Marketed Outside US
Source:
21 CFR 358H
(2012)
Source URL:
First approved in 2012
Source:
21 CFR 358H
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
21 CFR 333B
(2016)
Source URL:
First approved in 2012
Source:
21 CFR 352
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2015)
Source URL:
First approved in 2012
Source:
21 CFR 352
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
M020
(2012)
Source URL:
First approved in 2012
Source:
M020
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
M006
(2012)
Source URL:
First approved in 2012
Source:
M006
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
M006
(2024)
Source URL:
First approved in 2012
Source:
DOUBLE DINE by IBA
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
505G(a)(3)
(2012)
Source URL:
First approved in 2012
Source:
505G(a)(3)
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
21 CFR 346
(2012)
Source URL:
First approved in 2012
Source:
21 CFR 346
Source URL:
Class:
POLYMER