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Status:
US Approved Rx
(2016)
Source:
ANDA079167
(2016)
Source URL:
First approved in 2003
Source:
NDA021366
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
CRESTOR (rosuvastatin calcium) is an inhibitor of HMG-CoA reductase. It has been widely launched for the treatment of patients with dyslipidaemia and has also been approved in the US and EU to slow the progression of atherosclerosis.
Status:
US Approved Rx
(2010)
Source:
NDA050814
(2010)
Source URL:
First approved in 1986
Source:
NDA050580
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Aztreonam is the first monocyclic beta-lactam antibiotic (monobactam) originally isolated from Chromobacterium violaceum. Aztreonam has a high affinity for the protein-binding protein 3 (PBP-3) of aerobic gram-negative bacteria. Most of these organisms are inhibited and killed at low concentrations of the drug. Aztreonam must be administered as an intravenous or intramuscular injection (AZACTAM®), or inhaled (CAYSTON®). Aztreonam for injection is indicated for the treatment of the following infections caused by susceptible gram-negative microorganisms: urinary tract, lower respiratory tract, skin and skin-structure, intra-abdominal and gynecologic infections as well as for septicemia. Aztreonam for inhalation solution is indicated to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa.
Status:
US Approved Rx
(2018)
Source:
ANDA210175
(2018)
Source URL:
First approved in 1959
Source:
OPANA by ENDO PHARMS
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Oxymorphone is an analgesic that is FDA approved for the treatment of moderate to severe pain. It is also indicated for relief of anxiety in patients with dyspnea associated with pulmonary edema secondary to acute left ventricular dysfunction. Oxymorphone (brand names Opana, Numorphan, Numorphone) is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. Adverse reactions (≥ 2% of patients): seen with the immediate release tablet formulation Nausea, pyrexia, somnolence, vomiting, pruritus, headache, dizziness, constipation, and confusion. Concomitant use with serotonergic drugs may result in serotonin syndrome. Avoid use of mixed agonist/antagonist and partial agonist opioid analgesics with Opana because they may reduce analgesic effect of Opana or precipitate withdrawal symptoms.
Status:
US Approved OTC
Source:
21 CFR 341.18 cough/cold:expectorant guaifenesin
Source URL:
First approved in 1961
Source:
BRONKODYL GLYCERYL GUAIACOLATE by PRL
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Guaifenesin is an expectorant the action of which promotes or facilitates the removal of secretions from the respiratory tract. The precise mechanism of action of guaifenesin is not known; however, it is thought to act as an expectorant by increasing the volume and reducing the viscosity of secretions in the trachea and bronchi. In turn, this may increase the efficiency of the cough reflex and facilitate removal of the secretions. Guaifenesin is over-the-counter drug for the treatment of cough and common cold.
Status:
US Previously Marketed
Source:
DYNABAC by LILLY RES LABS
(1995)
Source URL:
First approved in 1995
Source:
DYNABAC by LILLY RES LABS
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Dirithromycin (Dynabac) is a macrolide glycopeptide antibiotic used to treat different types of bacterial infections, such as bronchitis, pneumonia, tonsillitis, skin infections. Dirithromycin is a semi-synthetic derivative of erythromycin - the hemi-aminal resulting from the condensation of (9S)-erythromycyclamine with 2-(2-methoxyethoxy) acetaldehyde. Being unstable under both acidic and alkaline conditions, dirithromycin functions as a more lipid-soluble prodrug for (9S)-erythromycyclamine. Erythromycylamine exerts its activity by binding to the 50S ribosomal subunits of susceptible mircoorganisms resulting in inhibition of protein synthesis. Dirithromycin has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections: Staphylococcus aureus (methicillin-susceptible strains only), Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, and Mycoplasma pneumoniae. Dirithromycin showed better activity in vitro against Campylobacter jejuni and Borrelia burgdorferi than erythromycin or clarithromycin but in general demonstrated less activity than erythromycin, clarithromycin, or azithromycin against a majority of microorganisms. The pharmacokinetic profile of dirithromycin has advantages over other microlides of once-daily dosing and high and prolonged tissue concentrations but adverse effect profiles similar to those of the other macrolides, with reported problems most often related to the gastrointestinal tract.
Status:
US Previously Marketed
Source:
LIVOSTIN by NOVARTIS
(1993)
Source URL:
First approved in 1993
Source:
LIVOSTIN by NOVARTIS
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Levocabastine (trade name Livo) is a selective second-generation H1-receptor antagonist used for allergic conjunctivitis. Levocabastine binds the G protein-coupled neurotensin receptor 2 (NTR2), but not NTR1, where it behaves as a weak partial inverse agonist. In an environmental study, LIVOSTIN 0.05% (levocabastine hydrochloride ophthalmic suspension) instilled four times daily was shown to be significantly more effective than its vehicle in reducing ocular itching associated with seasonal allergic conjunctivitis. After instillation in the eye, levocabastine is systemically absorbed. However, the amount of systemically absorbed levocabastine after therapeutic ocular doses is low (mean plasma concentrations in the range of 1-2 ng/mL). Brand name Livostin is no longer available in the U.S., but generic versions may still be available. Common side effects include burning, stinging, itching, or watering of the eyes, eye irritation or discomfort, blurred vision, dry or puffy eyes, headache, nosebleed, nausea, or fatigue.
Status:
US Previously Marketed
First approved in 1963
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
A synthetic, carbanilide compound with antiseptic activity. Cloflucarban is used as disinfectant and is found in antimicrobial soaps and deodorants. Cloflucarban remains Category II as a health care antiseptic for use as a patient preoperative skin preparation and surgical scrub and Category Ill for use as an antiseptic handwash.
Status:
US Approved Rx
(2016)
Source:
ANDA079167
(2016)
Source URL:
First approved in 2003
Source:
NDA021366
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
CRESTOR (rosuvastatin calcium) is an inhibitor of HMG-CoA reductase. It has been widely launched for the treatment of patients with dyslipidaemia and has also been approved in the US and EU to slow the progression of atherosclerosis.
Status:
US Approved Rx
(2016)
Source:
ANDA079167
(2016)
Source URL:
First approved in 2003
Source:
NDA021366
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
CRESTOR (rosuvastatin calcium) is an inhibitor of HMG-CoA reductase. It has been widely launched for the treatment of patients with dyslipidaemia and has also been approved in the US and EU to slow the progression of atherosclerosis.
Status:
US Approved Rx
(2016)
Source:
ANDA079167
(2016)
Source URL:
First approved in 2003
Source:
NDA021366
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
CRESTOR (rosuvastatin calcium) is an inhibitor of HMG-CoA reductase. It has been widely launched for the treatment of patients with dyslipidaemia and has also been approved in the US and EU to slow the progression of atherosclerosis.