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Search results for "PART 310 -- NEW DRUGS|Subpart E--Requirements for Specific New Drugs or Devices" in comments (approximate match)
Status:
US Previously Marketed
Source:
Belladonna Leaves U.S.P.
(1921)
Source URL:
First marketed in 1921
Source:
Belladonna Leaves U.S.P.
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
US Previously Marketed
Source:
Stramonium U.S.P.
(1921)
Source URL:
First marketed in 1921
Class:
STRUCTURALLY DIVERSE
Status:
US Previously Marketed
Source:
Oil of Eucalyptus U.S.P.
(1921)
Source URL:
First marketed in 1921
Source:
Oil of Eucalyptus U.S.P.
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
US Previously Marketed
Source:
Hydrastis U.S.P.
(1921)
Source URL:
First marketed in 1921
Class:
STRUCTURALLY DIVERSE
Status:
US Previously Marketed
Source:
21 CFR 310.528(a) aphrodisiac mandrake
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
Possibly Marketed Outside US
First approved in 2013
Source:
PAMO Kill Natural by GeoRim Pharmaceutical
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
Possibly Marketed Outside US
Class:
STRUCTURALLY DIVERSE
Status:
Possibly Marketed Outside US
Class:
STRUCTURALLY DIVERSE
Status:
US Approved Rx
(1978)
Source:
NDA017433
(1978)
Source URL:
First approved in 1948
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Hexachlorophene, also known as Nabac, is an organochlorine compound that was once widely used as a disinfectant. The compound occurs as a white odorless solid, although commercial samples can be off-white and possess a slightly phenolic odor. It is insoluble in water but dissolves in acetone, ethanol, diethyl ether, and chloroform. Exact mechanism(s) of action unknown, but at low concentrations appears to interrupt bacterial electron transport and inhibit membrane-bound enzymes. Higher concentrations rupture bacterial membranes. It induces leakage, causes protoplast lysis, and inhibits respiration. In medicine, hexachlorophene is a useful as a topical anti-infective, anti-bacterial agent, often used in soaps and toothpaste. It is also used in agriculture as a soil fungicide, plant bactericide, and acaricide.
Status:
US Approved Rx
(1972)
Source:
ANDA080556
(1972)
Source URL:
First approved in 1947
Source:
BEROCCA PN by ROCHE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Thiamine, also known as vitamin B1, plays a key role in the human metabolism. It is present in many dietary sources such as meats, eggs, fish, beans and peas, nuts, and whole grains. Upon administration thiamine is converted by thiamine
pyrophosphokinase-1 (TPK1) to the active form, thiamine pyrophosphate, which serves as a cofactor for enzymes involved in the TCA cycle and the non-oxidative part of the pentose phosphate pathway. The lack of thiamine may cause the thiamine deficiency. The classical syndrome caused primarily by thiamine deficiency in humans is beriberi, however, symptoms of thiamine deficiency also include congestive heart failure, metabolic acidosis, confusion, ataxia and seizures. Thiamine is a component of many vitamin complexes, which are approved for the treatmen and prevention of general vitamin deficiency, including the thiamine deficiency.