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Search results for lactic root_notes_note in Note (approximate match)
Status:
US Approved Rx
(1986)
Source:
ANDA071081
(1986)
Source URL:
First approved in 1980
Source:
MECLOMEN by PARKE DAVIS
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Meclofenamic acid, used as Meclofenamate sodium, is a non-steroidal anti-inflammatory agent with antipyretic and antigranulation activities. Meclofenamate sodium capsules are indicated for the relief of mild to moderate pain, for the treatment of primary dysmenorrhea and for the treatment of idiopathic heavy menstrual blood loss; for relief of signs and symptoms of juvenile arthritis; so as for relief of the signs and symptoms of rheumatoid arthritis; For relief of the signs and symptoms of osteoarthritis. The mode of action, like that of other nonsteroidal anti-inflammatory agents, is not known. Therapeutic action does not result from pituitary-adrenal stimulation. In animal studies, meclofenamate sodium was found to inhibit prostaglandin synthesis and to compete for binding at the prostaglandin receptor site. In vitro, meclofenamate sodium was found to be an inhibitor of human leukocyte 5-lipoxygenase activity. These properties may be responsible for the anti-inflammatory action of meclofenamate sodium. There is no evidence that meclofenamate sodium alters the course of the underlying disease.
Status:
US Approved Rx
(1993)
Source:
ANDA074201
(1993)
Source URL:
First approved in 1976
Source:
NDA017581
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Naproxen (naproxen sodium, NAPROSYN®) is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). It is an anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout. The mechanism of action of the naproxen (naproxen sodium, NAPROSYN®), like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).
Status:
US Approved Rx
(2016)
Source:
ANDA203323
(2016)
Source URL:
First approved in 1976
Source:
AMIKIN by APOTHECON
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Amikacin, USP (as the sulfate) is a semi-synthetic aminoglycoside antibiotic derived from kanamycin. Amikacin "irreversibly" binds to specific 30S-subunit proteins and 16S rRNA. Amikacin inhibits protein synthesis by binding to the 30S ribosomal subunit to prevent the formation of an initiation complex with messenger RNA. Specifically Amikacin binds to four nucleotides of 16S rRNA and a single amino acid of protein S12. This interferes with decoding site in the vicinity of nucleotide 1400 in 16S rRNA of 30S subunit. This region interacts with the wobble base in the anticodon of tRNA. This leads to interference with the initiation complex, misreading of mRNA so incorrect amino acids are inserted into the polypeptide leading to nonfunctional or toxic peptides and the breakup of polysomes into nonfunctional monosomes. Amikacin is used for short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella-Enterobacter-Serratia species, and Acinetobacter (Mima-Herellea) species. Amikacin may also be used to treat Mycobacterium avium and Mycobacterium tuberculosis infections. Amikacin was used for the treatment of gram-negative pneumonia.
Status:
US Approved Rx
(1975)
Source:
NDA017586
(1975)
Source URL:
First approved in 1975
Source:
NDA017586
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Gluconic acid is a natural compound
produced from glucose through a simple dehydrogenation reaction catalysed by glucose oxidase. Gluconic acid and its salts are
used in the formulation of food, pharmaceutical and hygienic products.
Status:
US Approved Rx
(2024)
Source:
ANDA215178
(2024)
Source URL:
First approved in 1974
Source:
DOXORUBICIN HYDROCHLORIDE by PFIZER
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Doxorubicin is an antineoplastic in the anthracycline class. General properties of drugs in this class include: interaction with DNA in a variety of different ways including intercalation (squeezing between the base pairs), DNA strand breakage and inhibition with the enzyme topoisomerase II. Most of these compounds have been isolated from natural sources and antibiotics. However, they lack the specificity of the antimicrobial antibiotics and thus produce significant toxicity. The anthracyclines are among the most important antitumor drugs available. Doxorubicin is widely used for the treatment of several solid tumors while daunorubicin and idarubicin are used exclusively for the treatment of leukemia. Doxorubicin may also inhibit polymerase activity, affect regulation of gene expression, and produce free radical damage to DNA. Doxorubicin possesses an antitumor effect against a wide spectrum of tumors, either grafted or spontaneous. Doxorubicin is used to produce regression in disseminated neoplastic conditions like acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms’ tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin’s disease, malignant lymphoma and bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types. Doxorubicin is also indicated for use as a component of adjuvant therapy in women with evidence of axillary lymph node involvement following resection of primary breast cancer.
Status:
US Approved Rx
(1974)
Source:
NDA017279
(1974)
Source URL:
First approved in 1974
Source:
NDA017279
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Iothalamic acid is a Radiographic Contrast Agent. The mechanism of action of iothalamic acid is as a X-Ray Contrast Activity. GLOFIL-125 (Sodium Iothalamate I-125 Injection) is a sterile, nonpyrogenic aqueous injection containing approximately 1 mg sodium iothalamate per mL, and 0.9 percent benzyl alcohol as a preservative. The radioactive concentration of the material is 250-300 µCi/mL as of the calibration date. Sodium bicarbonate and hydrochloric acid are present for pH adjustment. GLOFIL-125 (Sodium Iothalamate I-125 Injection) is indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease. The renal clearance of sodium iothalamate in man closely approximates that of inulin. The compound is cleared by glomerular filtration without tubular secretion or reabsorption. Following infusion administration of I-125 iothalamate, the effective half-life is about 0.07 days.
Status:
US Approved Rx
(1974)
Source:
NDA017538
(1974)
Source URL:
First approved in 1974
Source:
NDA017538
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Technetium TC 99M Pyrophosphate is a radionuclide imaging agent used primarily in scintigraphy or tomography of the heart to evaluate the extent of the necrotic myocardial process. It has also been used in noninvasive tests for the distribution of organ involvement in different types of amyloidosis and for the evaluation of muscle necrosis in the extremities. It is also used to demonstrate areas of altered osteogenesis. May also be used to image gated blood pools and detect gastrointetinal bleeding.
Status:
US Approved Rx
(1990)
Source:
NDA019785
(1990)
Source URL:
First approved in 1973
Source:
NDA017243
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Molybdenum-99 (99Mo, half-life = 66 h) is a parent radionuclide of a diagnostic nuclear isotope. It decays in technetium-99 m (half-life = 6 h), which is used in over 30 million procedures per year around the world. Between 95 and 98 percent of Mo-99 is currently being produced using highly enriched uranium (HEU) targets. Other medical isotopes such as iodine-131 (I-131) and xenon-133 (Xe-133) are by-products of the Mo-99 production process and will be sufficiently available if Mo-99 is available.
Status:
US Approved Rx
(2015)
Source:
ANDA204517
(2015)
Source URL:
First approved in 1972
Source:
FLUORINE F-18 by GE HEALTHCARE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
FLUORIDE ION F-18 (as sodium fluoride F-18) is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity. FLUORIDE ION F-18 normally accumulates in the skeleton in an even fashion, with greater deposition in the axial skeleton (e.g. vertebrae and pelvis) than in the appendicular skeleton and greater deposition in the bones around joints than in the shafts of long bones. Increased FLUORIDE ION F-18 deposition in the bone can occur in areas of increased osteogenic activity during growth, infection, malignancy (primary or metastatic) following trauma, or inflammation of the bone.
Status:
US Approved Rx
(2022)
Source:
ANDA213730
(2022)
Source URL:
First approved in 1972
Source:
NDA017105
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Clorazepate is a water-soluble benzodiazepine derivative effective in the treatment of anxiety. It has also muscle relaxant and anticonvulsant actions. Studies in healthy men have shown that clorazepate dipotassium has depressant effects on the central nervous system. clorazepate is a prodrug since orally administered it is rapidly decarboxylated to form nordiazepam, there is essentially no circulating parent drug. Nordiazepam positively modulates GABAA receptors to produce anxiolytic and anticonvulsant effects.