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Search results for l root_codes_comments in Code Comments (approximate match)
Status:
US Approved Allergenic Extract
(1967)
Source:
BLA101376
(1967)
Source URL:
First marketed in 1921
Class:
STRUCTURALLY DIVERSE
Status:
US Approved Allergenic Extract
(1972)
Source:
BLA102192
(1972)
Source URL:
First marketed in 1921
Class:
STRUCTURALLY DIVERSE
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(8)(ii) digestive aid senna
Source URL:
First approved in 2009
Source:
21 CFR 334
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(ii) skin protectant:astringent clove oil
Source URL:
First approved in 1994
Source:
LEG TIGHTENER by JACKS MFG INC
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(12)(iv)(A) laxative:stimulant laxative podophyllum resin (podophyllin)
Source URL:
First approved in 1990
Source:
Podocon 25 by Padagis US LLC
Source URL:
Class:
STRUCTURALLY DIVERSE
Conditions:
Podophyllum resin is the powdered mixture of resins removed from the May apple or Mandrake, a perennial plant of the northern and middle United States. The early colonists learned of themedical properties of the root from the Indians, and it was used as a cathartic in the firstUnited States Pharmacopoeia (1820). The resin, podophyllin, was first separated from Podophyllum by John King in 1835. Between 1863 and 1942, podophyllin was reported to be a cathartic, purgative, deobstruent, vermifuge, hydragogue, cholagogue, choleretic, andexpectorant.Itwas recommended, either alone or in combination with other herbs, for diseases of the liverandkidneys, for scrofula, syphilis, gonorrhea, obstructed menstruation, urinary obstruction, dropsy, and coughs. Currently Podophyllum resin is used as a medication to treat genital warts and plantar warts, including in people with HIV/AIDS. Common side effects include redness, itchiness, and pain at the site of use. Severe side effects may include vomiting, abdominal pain, confusion, bone marrow suppression, and diarrhea. It is not recommended for more than a small area at a time. Use during pregnancy is known to be dangerous to the baby.
Status:
Possibly Marketed Outside US
Source:
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm071835.htm laxative:stimulant laxative senna pod concentrate
Source URL:
First approved in 2019
Source:
LAXATIVES RUBILAX by Lydia Co., Ltd.
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
Possibly Marketed Outside US
First approved in 2001
Source:
Preferred Plus Urinary Pain Relief by Kinray
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
Possibly Marketed Outside US
First approved in 1950
Source:
21 CFR 348
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
US Previously Marketed
Source:
THYROLAR-0.25 by ALLERGAN
(1969)
Source URL:
First approved in 1969
Source:
THYROLAR-0.25 by ALLERGAN
Source URL:
Class:
G1 SPECIFIED SUBSTANCE
Status:
US Approved Rx
(2020)
Source:
NDA213036
(2020)
Source URL:
First approved in 2020
Source:
NDA213036
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Artenimol (dihydroartemisinin) is a derivate of antimalarial compound artemisinin. Artenimol (dihydroartemisinin) is able to reach high concentrations within the parasitized erythrocytes. Its endoperoxide bridge is thought to be essential for its antimalarial activity, causing free-radical damage to parasite membrane systems including:
• Inhibition of falciparum sarcoplasmic-endoplasmic reticulum calcium ATPase, • Interference with mitochondrial electron transport • Interference with parasite transport proteins • Disruption of parasite mitochondrial function. Dihydroartemisinin in combination with piperaquine tetraphosphate (Eurartesim, EMA-approved in 2011) is indicated for the treatment of uncomplicated Plasmodium falciparum malaria. The formulation meets WHO recommendations, which advise combination treatment for Plasmodium falciparum malaria to reduce the risk of resistance development, with artemisinin-based preparations regarded as the ‘policy standard’. However, experimental testing demonstrates that, due to its intrinsic chemical instability, dihydroartemisinin is not suitable to be used in pharmaceutical formulations. In addition, data show that the currently available dihydroartemisinin preparations fail to meet the internationally accepted stability requirements.