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Search results for vitamin root_references_citation in Reference Text / Citation (approximate match)
Status:
US Approved Rx
(2024)
Source:
ANDA217548
(2024)
Source URL:
First approved in 1988
Source:
CARDENE by CHIESI
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Nicardipine is a potent calcium channel blockader with marked vasodilator action used to treat high blood pressure and angina. By deforming the channel, inhibiting ion-control gating mechanisms, and/or interfering with the release of calcium from the sarcoplasmic reticulum, nicardipine inhibits the influx of extracellular calcium across the myocardial and vascular smooth muscle cell membranes The decrease in intracellular calcium inhibits the contractile processes of the myocardial smooth muscle cells, causing dilation of the coronary and systemic arteries, increased oxygen delivery to the myocardial tissue, decreased total peripheral resistance, decreased systemic blood pressure, and decreased afterload.
Status:
US Approved Rx
(2021)
Source:
ANDA213053
(2021)
Source URL:
First approved in 1987
Source:
BACTROBAN by GLAXOSMITHKLINE
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Mupirocin (BACTROBAN®) is an antibiotic from a strain of Pseudomonas fluorescens. It has shown excellent activity against gram-positive staphylococci and streptococci. The antibiotic is used primarily for the treatment of primary and secondary skin disorders, nasal infections, and wound healing. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyltransfer RNA (tRNA) synthetase. It also severely inhibits RNA synthesis. DNA and cell wall peptidoglycan synthesis are inhibited to a lesser extent and interference with these processes is considered to be a secondary effect. Mupirocin is bactericidal at concentrations achieved by topical administration.
Status:
US Approved Rx
(2006)
Source:
ANDA076871
(2006)
Source URL:
First approved in 1987
Source:
NOVANTRONE by EMD SERONO
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Mitoxantrone (NOVANTRONE) is a synthetic antineoplastic
anthracenedione. Mitoxantrone, a DNA-reactive agent that intercalates into deoxyribonucleic acid (DNA)
through hydrogen bonding, causes crosslinks and strand breaks. Mitoxantrone also interferes with ribonucleic acid (RNA) and is a potent inhibitor of topoisomerase II, an
enzyme responsible for uncoiling and repairing damaged DNA. It has a cytocidal effect
on both proliferating and nonproliferating cultured human cells, suggesting lack of cell
cycle phase specificity.
Mitoxantrone has been shown in vitro to inhibit B cell, T cell, and macrophage
proliferation and impair antigen pre sentation, as well as the secretion of interferon
gamma, TNFα, and IL-2. NOVANTRONE is indicated for reducing neurologic disability and/or the frequency of
clinical relapses in patients with secondary (chronic) progressive, progressive relapsing,
or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status
is significantly abnormal between relapses). NOVANTRONE in combination with corticosteroids is indicated as initial chemotherapy
for the treatment of patients with pain related to advanced hormone-refractory prostate
cancer.
NOVANTRONE in combination with other approved drug(s) is indicated in the initial
therapy of acute nonlymphocytic leukemia (ANLL) in adults. This category includes
myelogenous, promyelocytic, monocytic, and erythroid acute leukemias.
Status:
US Approved Rx
(2020)
Source:
ANDA212041
(2020)
Source URL:
First approved in 1987
Source:
PRINIVIL by MERCK
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Lisinopril is a potent, competitive inhibitor of angiotensin-converting enzyme (ACE). Lisinopril is marketed under the brand name ZESTRIL. ZESTRIL is indicated for the treatment of hypertension. It may be used alone as initial therapy
or concomitantly with other classes of antihypertensive agents. It is also indicated as adjunctive therapy in the management of heart failure in patients who
are not responding adequately to diuretics and digitalis. Lisinopril inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE
is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor
substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal
cortex. The beneficial effects of lisinopril in hypertension and heart failure appear to result
primarily from suppression of the renin-angiotensin-aldosterone system. Inhibition of ACE
results in decreased plasma angiotensin II which leads to decreased vasopressor activity and to
decreased aldosterone secretion. While the mechanism through which ZESTRIL lowers blood pressure is believed to be primarily
suppression of the renin-angiotensin-aldosterone system, ZESTRIL is antihypertensive even in
patients with low-renin hypertension.
Status:
US Approved Rx
(1999)
Source:
ANDA075221
(1999)
Source URL:
First approved in 1986
Source:
NDA019353
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Alfentanil is an opioid analgesic with a rapid onset of action. Alfentanil interacts predominately with the opioid mu-receptor. These mu-binding sites are discretely distributed in the human brain, spinal cord, and other tissues. In clinical settings, alfentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation. Alfentanil may increase the patient's tolerance for pain and decrease the perception of suffering, although the presence of the pain itself may still be recognized. In addition to analgesia, alterations in mood, euphoria and dysphoria, and drowsiness commonly occur. Alfentanil depresses the respiratory centers, depresses the cough reflex, and constricts the pupils. Alfentanil, marketed under the trade name Alfenta, Rapifen in Australia is indicated for the management of postoperative pain and the maintenance of general anesthesia.
Status:
US Approved Rx
(2014)
Source:
ANDA201995
(2014)
Source URL:
First approved in 1986
Source:
PEPCID by BAUSCH
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Famotidine, a competitive histamine H2-receptor antagonist, is used to treat gastrointestinal disorders such as gastric or duodenal ulcer, gastroesophageal reflux disease, and pathological hypersecretory conditions. Famotidine inhibits many of the isoenzymes of the hepatic CYP450 enzyme system. Other actions of Famotidine include an increase in gastric bacterial flora such as nitrate-reducing organisms. Famotidine binds competitively to H2-receptors located on the basolateral membrane of the parietal cell, blocking histamine affects. This competitive inhibition results in reduced basal and nocturnal gastric acid secretion and a reduction in gastric volume, acidity, and amount of gastric acid released in response to stimuli including food, caffeine, insulin, betazole, or pentagastrin.
Status:
US Approved Rx
(1985)
Source:
NDA019219
(1985)
Source URL:
First approved in 1985
Source:
NDA019219
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Levobunolol is a non-cardioselective beta-adrenoceptor blocking agent, equipotent at both beta1 and beta2 adrenergic receptors. Levobunolol is greater than 60 times more potent than its dextro isomer in its beta-blocking activity, yet equipotent in its potential for direct myocardial depression. Accordingly, the levo isomer, levobunolol, is used. Levobunolol does not have significant local anesthetic (membrane-stabilizing) or intrinsic sympathomimetic activity. Levobunolol, sold under the brand name Betagan, has been shown to be an active agent in lowering elevated as well as normal intraocular pressure (IOP) whether or not accompanied by glaucoma. Levobunolol is contraindicated in those individuals with bronchial asthma or with a history of bronchial asthma, or severe chronic obstructive pulmonary disease sinus bradycardia; second and third-degree atrioventricular block; overt cardiac failure cardiogenic shock; or hypersensitivity to any component of these products.
Status:
US Approved Rx
(2021)
Source:
ANDA212533
(2021)
Source URL:
First approved in 1985
Source:
NDA018948
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Levocarnitine propionate or Propionyl L-carnitine (PLC) is the propionyl ester of L-carnitine. Propionyl-L-carnitine stimulates energy production in ischaemic muscles by increasing citric acid cycle flux and stimulating pyruvate dehydrogenase activity. The free radical scavenging activity of the drug may also be beneficial. Propionyl-L-carnitine improves coagulative fibrinolytic homeostasis in vasal endothelium and positively affects blood viscosity. It exhibits a high affinity for the muscle enzyme, carnitine acyl transferase, and as such readily converts into propionyl-CoA and free carnitine. Most studies of the therapeutic use of PLC are focused on the prevention and treatment of ischemic heart disease, congestive heart failure, hypertrophic heart disease, and peripheral arterial disease. PLC is marketed under the trade name Dromos®. It is indicated for patients with peripheral arterial occlusive disorders and for exercise intolerance enhancement in patients with chronic congestive heart failure. Dromos is marketed in Italy.
Status:
US Approved Rx
(2000)
Source:
ANDA075479
(2000)
Source URL:
First approved in 1985
Source:
NDA018998
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Enalapril (marketed as Vasotec in the US, Enaladex and Renitec in some other countries) is an angiotensin-converting-enzyme (ACE) inhibitor used in the treatment of hypertension, diabetic nephropathy, and some types of chronic heart failure. Enalapril, after hydrolysis to enalaprilat, inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. The beneficial effects of enalapril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decrease aldosterone secretion.
Status:
US Approved Rx
(2019)
Source:
ANDA207594
(2019)
Source URL:
First approved in 1985
Source:
NDA050587
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Imipenem is a beta-lactam antibiotic belongings to the subgroup of carbapenems. Imipenem has a broad spectrum of activity against aerobic and anaerobic Gram positive as well as Gram negative bacteria. It is particularly important for its activity against Pseudomonas aeruginosa and the Enterococcus species. Imipenem is rapidly degraded by the renal enzyme dehydropeptidase when administered alone, and is always co-administered with cilastatin to prevent this inactivation. The bactericidal activity of imipenem results from the inhibition of cell wall synthesis. Its greatest affinity is for
penicillin binding proteins (PBPs) 1A, 1B, 2, 4, 5 and 6 of Escherichia coli, and 1A, 1B, 2, 4 and 5 of
Pseudomonas aeruginosa. The lethal effect is related to binding to PBP 2 and PBP 1B. Imipenem is marketed under the brand name Primaxin. PRIMAXIN I.M. (Imipenem and Cilastatin for Injectable Suspension) is a formulation of imipenem (a
thienamycin antibiotic) and cilastatin sodium (the inhibitor of the renal dipeptidase, dehydropeptidase I).
PRIMAXIN I.M. is a potent broad spectrum antibacterial agent for intramuscular administration.