{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
Showing 1 - 6 of 6 results
Status:
US Previously Marketed
Source:
glycolic acid
(2022)
Source URL:
First approved in 1947
Source:
NDA006188
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
SODIUM GLYCOLATE, a sodium salt of carboxymethyl ether, is used as a pharmaceutical grade dissolution excipient for solid dosage forms. It absorbs water rapidly, resulting in swelling which leads to the rapid disintegration of tablets and capsules. Without a disintegrant, these may not dissolve appropriately and may effect the amount of active ingredient absorbed, thereby decreasing effectiveness.
Status:
Possibly Marketed Outside US
Source:
PRISMASOL
Source URL:
First approved in 2005
Source:
ANDA076313
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Lactic Acid, L- (L-lactic acid, L-lactate) is the levorotatory isomer of lactic acid, the biologically active isoform in humans. Lactic acid or lactate is produced during fermentation from pyruvate by lactate dehydrogenase. Lactate dehydrogenase is isomer-specific so that production and metabolism of D-lactate require D-LDH and L-lactate requires L-LDH. Mammalian cells only contain L-LDH so that in humans the lactate produced is almost exclusively L-lactate. Carbohydrate-fermenting bacterial species (e.g. lactobacillus spp) have by contrast both enzymes and therefore the capacity to produce both D-lactate and L-lactate. L-lactic acid is the primary agonist of hydroxycarboxylic acid receptor 1 (HCA1), which is a Gi/o-coupled G protein-coupled receptor (GPCR). Poly-L-lactic acid is an absorbable, semi-permanent, injectable implant that can be used to restore volume and stimulate collagen formation gradually. It is FDA-approved for the correction of facial fat loss associated with antiretroviral therapy-induced lipoatrophy in HIV patients. It is FDA-approved for use in immunocompetent people for the correction of nasolabial fold deficiencies and other facial wrinkles. It has been used off-label to enhance the cheeks, hands, neck, thighs, gluteal enhancement and chest wall deformities, such as pectus excavatum or thoracic deformities secondary to surgical procedures.
Status:
US Previously Marketed
Source:
glycolic acid
(2022)
Source URL:
First approved in 1947
Source:
NDA006188
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
SODIUM GLYCOLATE, a sodium salt of carboxymethyl ether, is used as a pharmaceutical grade dissolution excipient for solid dosage forms. It absorbs water rapidly, resulting in swelling which leads to the rapid disintegration of tablets and capsules. Without a disintegrant, these may not dissolve appropriately and may effect the amount of active ingredient absorbed, thereby decreasing effectiveness.
Status:
US Previously Marketed
Source:
glycolic acid
(2022)
Source URL:
First approved in 1947
Source:
NDA006188
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
SODIUM GLYCOLATE, a sodium salt of carboxymethyl ether, is used as a pharmaceutical grade dissolution excipient for solid dosage forms. It absorbs water rapidly, resulting in swelling which leads to the rapid disintegration of tablets and capsules. Without a disintegrant, these may not dissolve appropriately and may effect the amount of active ingredient absorbed, thereby decreasing effectiveness.
Status:
Possibly Marketed Outside US
Source:
PRISMASOL
Source URL:
First approved in 2005
Source:
ANDA076313
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Lactic Acid, L- (L-lactic acid, L-lactate) is the levorotatory isomer of lactic acid, the biologically active isoform in humans. Lactic acid or lactate is produced during fermentation from pyruvate by lactate dehydrogenase. Lactate dehydrogenase is isomer-specific so that production and metabolism of D-lactate require D-LDH and L-lactate requires L-LDH. Mammalian cells only contain L-LDH so that in humans the lactate produced is almost exclusively L-lactate. Carbohydrate-fermenting bacterial species (e.g. lactobacillus spp) have by contrast both enzymes and therefore the capacity to produce both D-lactate and L-lactate. L-lactic acid is the primary agonist of hydroxycarboxylic acid receptor 1 (HCA1), which is a Gi/o-coupled G protein-coupled receptor (GPCR). Poly-L-lactic acid is an absorbable, semi-permanent, injectable implant that can be used to restore volume and stimulate collagen formation gradually. It is FDA-approved for the correction of facial fat loss associated with antiretroviral therapy-induced lipoatrophy in HIV patients. It is FDA-approved for use in immunocompetent people for the correction of nasolabial fold deficiencies and other facial wrinkles. It has been used off-label to enhance the cheeks, hands, neck, thighs, gluteal enhancement and chest wall deformities, such as pectus excavatum or thoracic deformities secondary to surgical procedures.
Status:
Possibly Marketed Outside US
Source:
PRISMASOL
Source URL:
First approved in 2005
Source:
ANDA076313
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Lactic Acid, L- (L-lactic acid, L-lactate) is the levorotatory isomer of lactic acid, the biologically active isoform in humans. Lactic acid or lactate is produced during fermentation from pyruvate by lactate dehydrogenase. Lactate dehydrogenase is isomer-specific so that production and metabolism of D-lactate require D-LDH and L-lactate requires L-LDH. Mammalian cells only contain L-LDH so that in humans the lactate produced is almost exclusively L-lactate. Carbohydrate-fermenting bacterial species (e.g. lactobacillus spp) have by contrast both enzymes and therefore the capacity to produce both D-lactate and L-lactate. L-lactic acid is the primary agonist of hydroxycarboxylic acid receptor 1 (HCA1), which is a Gi/o-coupled G protein-coupled receptor (GPCR). Poly-L-lactic acid is an absorbable, semi-permanent, injectable implant that can be used to restore volume and stimulate collagen formation gradually. It is FDA-approved for the correction of facial fat loss associated with antiretroviral therapy-induced lipoatrophy in HIV patients. It is FDA-approved for use in immunocompetent people for the correction of nasolabial fold deficiencies and other facial wrinkles. It has been used off-label to enhance the cheeks, hands, neck, thighs, gluteal enhancement and chest wall deformities, such as pectus excavatum or thoracic deformities secondary to surgical procedures.