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Status:
Possibly Marketed Outside US
Source:
ANDA202933
(2007)
Source URL:
First approved in 1987
Source:
ANDA065166
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Succinimidyl-4-(N-maleimidomethyl)cyclohexane-1-carboxylate (SMCC), an N-hydroxysuccinimide ester derived from 4-(N-maleimidomethyl)cyclohexane-1-carboxylic acid, is a non-cleavable and membrane permeable crosslinker. It is used for enzyme labelling of antibodies - both enzyme and antibody specificity can be preserved; for creation of specific bioconjugates via one- or two-step crosslinking reactions; for creation of sulfhydryl-reactive, maleimide-activated carrier proteins for coupling haptens. SMCC conjugation occurs via a maleimide group that is sulfhydryl (thiol; -SH) reactive and a NHS ester group that is amine reactive and forms stable, covalent protein crosslinks. SMCC crosslinker must be dissolved in an organic solvent, such as DMSO or DMF, and then can be added to an aqueous crosslinking reaction. SMCC crosslinking reagent is permeable across the lipid bilayer of the cell membrane and can be used to crosslink intracellular proteins and peptides.
Status:
Possibly Marketed Outside US
Source:
Finaplix®-H by Roussel-Uclaf
Source URL:
First approved in 1987
Source:
NADA138612
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Trenbolone is an anabolic steroid. It is used on livestock to increase muscle growth and appetite. Trenbolone compounds have a binding affinity for the androgen receptor three times as high as that of testosterone. Once metabolized, the drugs have the effect of increasing nitrogen uptake by muscles, leading to an increase in the rate of protein synthesis. It also has the secondary effects of stimulating appetite, reducing the amount of fat being deposited in the body, and decreasing the rate of catabolism. Short-term side effects include insomnia, high blood pressure, increased aggression, night sweats, and libido.
Status:
Possibly Marketed Outside US
Source:
M020
(2014)
Source URL:
First approved in 1987
Source:
M016
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Distearyl dimethyl ammonium bromide (or dimethyldioctadecylammonium bromide (or DDA), a quaternary ammonium salt, that stimulates immune responses and binds to antigens. DDA enhances the immunogenicity of the soluble antigen. It was shown, that complexes of DDA and antigen were effective in eliciting a delayed hypersensitivity reaction, which was desirable for an antitumor effect. Besides, as a part of liposomal adjuvants, DDA can modulate T-helper 1-immune responses.
Status:
Possibly Marketed Outside US
Source:
ANDA070433
(1987)
Source URL:
First approved in 1987
Source:
ANDA070433
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Water O-15 as a diagnostic agent that was used in H215O-positron emission tomography/magnetic resonance imaging for noninvasive measurement of cerebral blood flow.
Status:
Possibly Marketed Outside US
Source:
Equestrolin
Source URL:
First approved in 1987
Source:
ANDA211721
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Luprostiol is a synthetic prostaglandin F2α and is a luteolytic agent. It is used for estrus control and termination of pregnancy in mares. In cattle Luprostiol is indicated for:
- Oestrus regulation / oestrus synchronization;
- Treatment of suboestrus;
- Induction of abortion;
- Induction of parturition;
- Treatment of pyometra, chronic endometritis and fetal mummification.
Status:
Possibly Marketed Outside US
First approved in 1987
Source:
NDA018963
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Mebrofenin is a chelating component which, when attached to Technetium TC-99M, forms a diagnostic drug marketed under the name Choletec. Choletec is approved by FDA as a hepatobiliary imaging agent.
Status:
Possibly Marketed Outside US
First approved in 1987
Source:
NDA021830
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Dibutyl phthalate (DBP) is used to help make plastics soft and flexible. It is used in shower curtains, raincoats, food wraps, bowls, car interiors, vinyl fabrics, floor tiles, and other products. Animal studies have reported developmental and reproductive effects from oral exposure. Dibutyl phthalate (DBP) is classified as a substance toxic to reproduction. No information is available on the carcinogenic effects of dibutyl phthalate in humans or animals. Treatment with dibutyl phthalate enhanced Aryl Hydrocarbon Receptor mRNA expression, which was reflected by the increased AhR protein level. ERα, ERβ, and PPARγ antagonists stimulated DBP-induced caspase-3 and LDH activities. AhR is involved in DBP-induced apoptosis and neurotoxicity, while the ERs and PPARγ signaling pathways are impaired by the phthalate. In vitro test showed that DBP killed all Demodex mites within 1 hour. Dibutyl phthalate emulsion is promising to be developed as a safe, effective therapeutic medicament on demodicidosis.
Status:
Possibly Marketed Outside US
Source:
ORANGE BOOK:SODIUM ACETATE ANHYDROUS [ORANGE BOOK]
Source URL:
First approved in 1987
Source:
NDA021318
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
Rejuvesol
Source URL:
First approved in 1987
Source:
21 CFR 349
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
CTI-01 (ethyl pyruvate) is an investigational anti-inflammatory agent for the treatment of critical inflammatory conditions. CTI-01 was developed by Critical Therapeutics as a stable prodrug of pyruvate, a potent antioxidant, and a free radical scavenger. The drug showed an anti-inflammatory and tissue protection activity in animal models of pancreatitis, ischemia-reperfusion injury, sepsis, renal injury, and endotoxemia. CTI-01 was investigated in phase 2 clinical trials on patients undergoing cardiac surgery with cardiopulmonary bypass, but despite positive results in animal models, administration of EP does not appear to confer any benefit to cardiac surgical patients undergoing cardiopulmonary bypass. Besides clinical applications, ethyl pyruvate is long used as an additive to pharmaceutical preparations and foods, including candy, beverages, and baked goods. It is generally recognized as safe by the FDA.
Status:
Possibly Marketed Outside US
Source:
BLA101066
(1986)
Source URL:
First approved in 1986
Source:
BLA101066
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)