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Status:
Possibly Marketed Outside US
First approved in 1978
Source:
NDA020963
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Benzododecinium, a quaternary ammonium compound, is an antiseptic agent and disinfectant. Benzododecinium is used as preservative in different pharmaceutical formulations. Thus, the dispenser of Timoptol-LA, used for the treatment of patients with ocular hypertension, contains benzododecinium bromide as a preservative. It is used as preservative and the corneal permeability enhancer in formulation. Benzododecinium is effective against gram-positive microbes.
Status:
Possibly Marketed Outside US
First approved in 1978
Source:
NDA020963
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Benzododecinium, a quaternary ammonium compound, is an antiseptic agent and disinfectant. Benzododecinium is used as preservative in different pharmaceutical formulations. Thus, the dispenser of Timoptol-LA, used for the treatment of patients with ocular hypertension, contains benzododecinium bromide as a preservative. It is used as preservative and the corneal permeability enhancer in formulation. Benzododecinium is effective against gram-positive microbes.
Status:
Possibly Marketed Outside US
First approved in 1972
Source:
ANDA210043
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Miripirium chloride is used as an antimicrobial preservative in
some pharmaceutical products. Miripirium was used as the preservative in Depo-Medrol. Miripirium was used as constituent of methylprednisolone acetate suspensions used for intra-articular corticosteroid therapy.
Status:
Possibly Marketed Outside US
Source:
Vedrop by Eastman Kodak
Source URL:
First approved in 1964
Source:
NADA012635
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Tocophersolan (Vedrop, tocofersolan) or d-alpha-Tocopheryl Polyethylene Glycol 1000 Succinate (TPGS) is a watersoluble derivative of the natural active (d-alpha) isomer of vitamin E. The active constituent of the medicinal product is essentially vitamin E (alpha tocopherol). Chronic congenital or hereditary cholestasis is a clinical condition where vitamin E deficiency results from an impaired bile secretion. Decreased intestinal absorption observed in chronic congenital or hereditary cholestatic patients is due to decreased bile secretion and the resulting decrease in intestinal cellular absorption. As a result, fatsoluble vitamins (i.e. vit. E) are not absorbed properly and deficiency can occur. Tocophersolan (Vedrop) is used to treat or prevent vitamin E deficiency (low vitamin E levels). It is used in children up to the age of 18 years who have congenital or hereditary chronic cholestasis and who cannot absorb vitamin E from the gut. Tocophersolan (Tocofersolan) can be absorbed from the gut in children who have difficulty absorbing fats and vitamin E from the diet. This can increase vitamin E levels in the blood and help to prevent neurological deterioration (problems in the nervous system) due to vitamin E deficiency. No treatment-related findings were reported, as all clinical observations and findings at autopsy were similar in treatment and control groups. In many of the studies, the LD50 was not
determined as tocofersolan was well tolerated.
Status:
Possibly Marketed Outside US
Source:
Vedrop by Eastman Kodak
Source URL:
First approved in 1964
Source:
NADA012635
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Tocophersolan (Vedrop, tocofersolan) or d-alpha-Tocopheryl Polyethylene Glycol 1000 Succinate (TPGS) is a watersoluble derivative of the natural active (d-alpha) isomer of vitamin E. The active constituent of the medicinal product is essentially vitamin E (alpha tocopherol). Chronic congenital or hereditary cholestasis is a clinical condition where vitamin E deficiency results from an impaired bile secretion. Decreased intestinal absorption observed in chronic congenital or hereditary cholestatic patients is due to decreased bile secretion and the resulting decrease in intestinal cellular absorption. As a result, fatsoluble vitamins (i.e. vit. E) are not absorbed properly and deficiency can occur. Tocophersolan (Vedrop) is used to treat or prevent vitamin E deficiency (low vitamin E levels). It is used in children up to the age of 18 years who have congenital or hereditary chronic cholestasis and who cannot absorb vitamin E from the gut. Tocophersolan (Tocofersolan) can be absorbed from the gut in children who have difficulty absorbing fats and vitamin E from the diet. This can increase vitamin E levels in the blood and help to prevent neurological deterioration (problems in the nervous system) due to vitamin E deficiency. No treatment-related findings were reported, as all clinical observations and findings at autopsy were similar in treatment and control groups. In many of the studies, the LD50 was not
determined as tocofersolan was well tolerated.
Status:
Possibly Marketed Outside US
Source:
Vedrop by Eastman Kodak
Source URL:
First approved in 1964
Source:
NADA012635
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Tocophersolan (Vedrop, tocofersolan) or d-alpha-Tocopheryl Polyethylene Glycol 1000 Succinate (TPGS) is a watersoluble derivative of the natural active (d-alpha) isomer of vitamin E. The active constituent of the medicinal product is essentially vitamin E (alpha tocopherol). Chronic congenital or hereditary cholestasis is a clinical condition where vitamin E deficiency results from an impaired bile secretion. Decreased intestinal absorption observed in chronic congenital or hereditary cholestatic patients is due to decreased bile secretion and the resulting decrease in intestinal cellular absorption. As a result, fatsoluble vitamins (i.e. vit. E) are not absorbed properly and deficiency can occur. Tocophersolan (Vedrop) is used to treat or prevent vitamin E deficiency (low vitamin E levels). It is used in children up to the age of 18 years who have congenital or hereditary chronic cholestasis and who cannot absorb vitamin E from the gut. Tocophersolan (Tocofersolan) can be absorbed from the gut in children who have difficulty absorbing fats and vitamin E from the diet. This can increase vitamin E levels in the blood and help to prevent neurological deterioration (problems in the nervous system) due to vitamin E deficiency. No treatment-related findings were reported, as all clinical observations and findings at autopsy were similar in treatment and control groups. In many of the studies, the LD50 was not
determined as tocofersolan was well tolerated.
Status:
Possibly Marketed Outside US
Source:
Vedrop by Eastman Kodak
Source URL:
First approved in 1964
Source:
NADA012635
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Tocophersolan (Vedrop, tocofersolan) or d-alpha-Tocopheryl Polyethylene Glycol 1000 Succinate (TPGS) is a watersoluble derivative of the natural active (d-alpha) isomer of vitamin E. The active constituent of the medicinal product is essentially vitamin E (alpha tocopherol). Chronic congenital or hereditary cholestasis is a clinical condition where vitamin E deficiency results from an impaired bile secretion. Decreased intestinal absorption observed in chronic congenital or hereditary cholestatic patients is due to decreased bile secretion and the resulting decrease in intestinal cellular absorption. As a result, fatsoluble vitamins (i.e. vit. E) are not absorbed properly and deficiency can occur. Tocophersolan (Vedrop) is used to treat or prevent vitamin E deficiency (low vitamin E levels). It is used in children up to the age of 18 years who have congenital or hereditary chronic cholestasis and who cannot absorb vitamin E from the gut. Tocophersolan (Tocofersolan) can be absorbed from the gut in children who have difficulty absorbing fats and vitamin E from the diet. This can increase vitamin E levels in the blood and help to prevent neurological deterioration (problems in the nervous system) due to vitamin E deficiency. No treatment-related findings were reported, as all clinical observations and findings at autopsy were similar in treatment and control groups. In many of the studies, the LD50 was not
determined as tocofersolan was well tolerated.
Status:
Possibly Marketed Outside US
Source:
Vedrop by Eastman Kodak
Source URL:
First approved in 1964
Source:
NADA012635
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Tocophersolan (Vedrop, tocofersolan) or d-alpha-Tocopheryl Polyethylene Glycol 1000 Succinate (TPGS) is a watersoluble derivative of the natural active (d-alpha) isomer of vitamin E. The active constituent of the medicinal product is essentially vitamin E (alpha tocopherol). Chronic congenital or hereditary cholestasis is a clinical condition where vitamin E deficiency results from an impaired bile secretion. Decreased intestinal absorption observed in chronic congenital or hereditary cholestatic patients is due to decreased bile secretion and the resulting decrease in intestinal cellular absorption. As a result, fatsoluble vitamins (i.e. vit. E) are not absorbed properly and deficiency can occur. Tocophersolan (Vedrop) is used to treat or prevent vitamin E deficiency (low vitamin E levels). It is used in children up to the age of 18 years who have congenital or hereditary chronic cholestasis and who cannot absorb vitamin E from the gut. Tocophersolan (Tocofersolan) can be absorbed from the gut in children who have difficulty absorbing fats and vitamin E from the diet. This can increase vitamin E levels in the blood and help to prevent neurological deterioration (problems in the nervous system) due to vitamin E deficiency. No treatment-related findings were reported, as all clinical observations and findings at autopsy were similar in treatment and control groups. In many of the studies, the LD50 was not
determined as tocofersolan was well tolerated.
Status:
Possibly Marketed Outside US
First approved in 1963
Source:
NADA038281
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Ethoxyquin (EQ) has been used as an antioxidant in animal feed for many years, but pharmacological use of EQ has never been evaluated in humans despite that small
amounts of EQ exist in certain food items. The level of this antioxidant in animal feeds should not be higher than 150 ppm (U.S. FDA permissions). Ethoxyquin is rapidly absorbed from gastrointestinal tract of laboratory animals like rats and mice. Peak blood concentration of the compound is observed within 1 h. Distribution of EQ in animal body is similar when it is administered orally and intravenously. Small amounts of parent EQ were detected in liver, kidney, and adipose tissue and fish muscles. It is excreted predominantly as metabolites via urine. Ethoxyquin is also registered as an antioxidant to control scald (browning) in apples and pears. EQ-induced DNA damage in human lymphocytes in a dose-dependent manner. According to the studies on dogs and laboratory animals it was shown that ethoxyquin had little acute toxicity, except when it is administered parenterally. Values of LD50 for EQ are 1700 mg kg−1 bw (rats, oral gavage), 2000 mg kg−1 bw (rats, dermal treatment, 24 h), 900 mg kg−1 bw (mice, intraperitoneal administration), and 180 mg kg−1 bw (mice, intravenous administration).
Status:
Possibly Marketed Outside US
Source:
KERR 100 TRIPLE DYE
Source URL:
First approved in 1960
Source:
Pad Kote by Happy Jack Inc
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Brilliant green is a synthetic dye. Brilliant green inhibits the growth of gram-positive bacterias and thus has antibacterial properties. It is broadly used as a topical antiseptic (in form of cutaneous solution), especially in Russia and Eastern Europe.