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aurobindo pharma limited - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - - clopidogrel tablets are indicated to reduce the rate of myocardial infarction (mi) and stroke in patients with non–st-segment elevation acs (unstable angina [ua]/non–st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. clopidogrel tablets should be administered in conjunction with aspirin. - clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute st-elevation myocardial infarction (stemi) who are to be managed medically. clopidogrel tablets should be administered in conjunction with aspirin.     in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopidogrel tablets are indicated to reduce the rate of mi and stroke. clopidogrel tablets  are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. clopidogrel tablets

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pd-rx pharmaceuticals, inc. - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - - clopidogrel tablets are indicated to reduce the rate of myocardial infarction (mi) and stroke in patients with non–st-segment elevation acs (unstable angina [ua]/non–st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. clopidogrel tablets should be administered in conjunction with aspirin. - clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute st-elevation myocardial infarction (stemi) who are to be managed medically. clopidogrel tablets should be administered in conjunction with aspirin. in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopidogrel tablets are indicated to reduce the rate of mi and stroke. clopidogrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. clopidogrel tablets are c

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vensun pharmaceuticals, inc. - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - - clopidogrel is indicated to reduce the rate of myocardial infarction (mi) and stroke in patients with non–st-segment elevation acs (unstable angina [ua]/ non–st -elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. clopidogrel should be administered in conjunction with aspirin. - clopidogrel is indicated to reduce the rate of myocardial infarction and stroke in patients with acute st-elevation myocardial infarction (stemi) who are to be managed medically. clopdiogrel should be administered in conjunction with aspirin. in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopdigorel is indicated to reduce the rate of mi and stroke. clopidogrel is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. clopidogrel is contraindicated in patients with hypersensitivity (e.g., an

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citron pharma llc - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - - for patients with non-st-segment elevation acs [unstable angina (ua)/non-st-elevation myocardial infarction (nstemi)], including patients who are to be managed medically and those who are to be managed with coronary revascularization, clopidogrel tablets, usp have been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (mi), or stroke as well as the rate of a combined endpoint of cardiovascular death, mi, stroke, or refractory ischemia. - for patients with st-elevation myocardial infarction (stemi), clopidogrel tablets, usp have been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. the benefit for patients who undergo primary percutaneous coronary intervention is unknown. the optimal duration of clopidogrel tablets, usp therapy in acs is unknown. for patients with a history of recent myocardial infarction (mi), recent stroke, or established peripheral arterial disease, clopidogrel tablets, u

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proficient rx lp - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg -  the optimal duration of clopidogrel therapy in acs is unknown. for patients with a history of recent myocardial infarction (mi), recent stroke, or established peripheral arterial disease, clopidogrel has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new mi (fatal or not), and other vascular death. clopidogrel is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. clopidogrel are contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see adverse reactions (6.2) ]. pregnancy category b reproduction studies performed in rats and rabbits at doses up to 500 and 300 mg/kg/day, respectively (65 and 78 times the recommended daily human dose, respectively, on a mg/m2 basis), revealed no evidence of impaired fertility or fetotoxicity due to clopidogrel. there are, however, no adequate and well-controlled studies in pregnant women. because animal repr

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blenheim pharmacal, inc. - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - the optimal duration of clopidogrel bisulfate therapy in acs is unknown. for patients with a history of recent myocardial infarction (mi), recent stroke, or established peripheral arterial disease, clopidogrel bisulfate has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new mi (fatal or not), and other vascular death. clopidogrel bisulfate is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. clopidogrel bisulfate is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see adverse reactions (6.2)] . reproduction studies performed in rats and rabbits at doses up to 500 and 300 mg/kg/day, respectively (65 and 78 times the recommended daily human dose, respectively, on a mg/m2 basis), revealed no evidence of impaired fertility or fetotoxicity due to clopidogrel. there are, however, no adequate and well-controlled studies in pregnant women. beca

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nucarepharmaceuticals, inc. - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine 40 mg - fluoxetine is indicated for the treatment of: • acute and maintenance treatment of major depressive disorder [see clinical studies ( 14.1)]. • acute and maintenance treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd) [see clinical studies ( 14.2)]. • acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa [see clinical studies ( 14.3)]. • acute treatment of panic disorder, with or without agoraphobia [see clinical studies ( 14.4)]. fluoxetine  and olanzapine in combination is indicated for the treatment of: • acute treatment of depressive episodes associated with bipolar i disorder. fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with bipolar

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astrazeneca pharmaceuticals lp - dapagliflozin propanediol (unii: 887k2391vh) (dapagliflozin - unii:1ull0qj8uc) - dapagliflozin 5 mg - farxiga (dapagliflozin) is indicated: limitations of use based on animal data showing adverse renal effects, farxiga is not recommended during the second and third trimesters of pregnancy. limited data with farxiga in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes and untreated heart failure in pregnancy (see clinical considerations) . in animal studies, adverse renal pelvic and tubule dilatations, that were not fully reversible, were observed in rats when dapagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy, at all doses tested; the lowest of which provided an exposure 15-times the 10 mg clinical dose (see data). the estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a hba1c greater than 7% and has been reported to be as high as 20 to 25% in women with hba1c greater than 10%. the estimated background risk of miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryofetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. data animal data dapagliflozin dosed directly to juvenile rats from postnatal day (pnd) 21 until pnd 90 at doses of 1, 15, or 75 mg/kg/day, increased kidney weights and increased the incidence of renal pelvic and tubular dilatations at all dose levels. exposure at the lowest dose tested was 15-times the 10 mg clinical dose (based on auc). the renal pelvic and tubular dilatations observed in juvenile animals did not fully reverse within a 1-month recovery period. in a prenatal and postnatal development study, dapagliflozin was administered to maternal rats from gestation day 6 through lactation day 21 at doses of 1, 15, or 75 mg/kg/day, and pups were indirectly exposed in utero and throughout lactation. increased incidence or severity of renal pelvic dilatation was observed in 21-day-old pups offspring of treated dams at 75 mg/kg/day (maternal and pup dapagliflozin exposures were 1415-times and 137-times, respectively, the human values at the 10 mg clinical dose, based on auc). dose-related reductions in pup body weights were observed at greater or equal to 29-times the 10 mg clinical dose (based on auc). no adverse effects on developmental endpoints were noted at 1 mg/kg/day (19-times the 10 mg clinical dose, based on auc). these outcomes occurred with drug exposure during periods of renal development in rats that corresponds to the late second and third trimester of human development. in embryofetal development studies in rats and rabbits, dapagliflozin was administered throughout organogenesis, corresponding to the first trimester of human pregnancy. in rats, dapagliflozin was neither embryolethal nor teratogenic at doses up to 75 mg/kg/day (1441-times the 10 mg clinical dose, based on auc). dose-related effects on the rat fetus (structural abnormalities and reduced body weight) occurred only at higher dosages, equal to or greater than 150 mg/kg (more than 2344-times the 10 mg clinical dose, based on auc), which were associated with maternal toxicity. no developmental toxicities were observed in rabbits at doses up to 180 mg/kg/day (1191-times the 10 mg clinical dose, based on auc). risk summary there is no information regarding the presence of dapagliflozin in human milk, the effects on the breastfed infant, or the effects on milk production. dapagliflozin is present in the milk of lactating rats (see data) . however, due to species-specific differences in lactation physiology, the clinical relevance of these data is not clear. since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney. because of the potential for serious adverse reactions in breastfed infants, advise women that use of farxiga is not recommended while breastfeeding. data dapagliflozin was present in rat milk at a milk/plasma ratio of 0.49, indicating that dapagliflozin and its metabolites are transferred into milk at a concentration that is approximately 50% of that in maternal plasma. juvenile rats directly exposed to dapagliflozin showed risk to the developing kidney (renal pelvic and tubular dilatations) during maturation. safety and effectiveness of farxiga in pediatric patients under 18 years of age have not been established. no farxiga dosage change is recommended based on age. a total of 1424 (24%) of the 5936 farxiga-treated patients were 65 years and older and 207 (3.5%) patients were 75 years and older in a pool of 21 double-blind, controlled, clinical studies assessing the efficacy of farxiga in improving glycemic control in type 2 diabetes mellitus. after controlling for level of renal function (egfr), efficacy was similar for patients under age 65 years and those 65 years and older. in patients ≥65 years of age, a higher proportion of patients treated with farxiga for glycemic control had adverse reactions of hypotension [see warnings and precautions (5.2) and adverse reactions (6.1)] . in the dapa-ckd, dapa-hf and deliver studies, safety and efficacy were similar for patients age 65 years and younger and those older than 65. in the dapa-hf study, 2714 (57%) out of 4744 patients with hfref were older than 65 years. in the deliver study, 4759 (76%) out of 6263 patients with heart failure (lvef >40%) were older than 65 years. in the dapa-ckd study, 1818 (42%) out of 4304 patients with ckd were older than 65 years. farxiga was evaluated in 4304 patients with chronic kidney disease (egfr 25 to 75 ml/min/1.73 m2 ) in the dapa-ckd study. farxiga was also evaluated in 1926 patients with an egfr of 30 to 60 ml/min/1.73 m2 in the dapa-hf study. the safety profile of farxiga across egfr subgroups in these studies was consistent with the known safety profile [see adverse reactions (6.1) and clinical studies (14.3 and 14.4)]. farxiga was evaluated in two glycemic control studies that included patients with type 2 diabetes mellitus with moderate renal impairment (an egfr of 45 to less than 60 ml/min/1.73 m2 [see clinical studies (14.1)] , and an egfr of 30 to less than 60 ml/min/1.73 m2 , respectively). patients with diabetes and renal impairment using farxiga may be more likely to experience hypotension and may be at higher risk for acute kidney injury secondary to volume depletion. in the study of patients with an egfr 30 to less than 60 ml/min/1.73 m2 , 13 patients receiving farxiga experienced bone fractures compared to none receiving placebo. use of farxiga for glycemic control in patients without established cv disease or cv risk factors is not recommended when egfr is less than 45 ml/min/1.73 m2 [see dosage and administration (2.2)] . efficacy and safety studies with farxiga did not enroll patients with an egfr less than 25 ml/min/1.73 m2 or on dialysis. no dose adjustment is recommended for patients with mild, moderate, or severe hepatic impairment. however, the benefit-risk for the use of dapagliflozin in patients with severe hepatic impairment should be individually assessed since the safety and efficacy of dapagliflozin have not been specifically studied in this population [see clinical pharmacology (12.3)] .

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avkare - diltiazem hydrochloride (unii: olh94387te) (diltiazem - unii:ee92bbp03h) - diltiazem hydrochloride 120 mg - diltiazem hydrochloride extended-release capsules, usp is indicated for the treatment of hypertension. it may be used alone or in combination with other antihypertensive medications. diltiazem hydrochloride extended-release capsules, usp is indicated for the management of chronic stable angina and angina due to coronary artery spasm. diltiazem hydrochloride is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree av block except in the presence of a functioning ventricular pacemaker, (3) patients with hypotension (less than 90 mm hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.

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lake erie medical dba quality care products llc - diltiazem hydrochloride (unii: olh94387te) (diltiazem - unii:ee92bbp03h) - diltiazem hydrochloride 180 mg - diltiazem hydrochloride extended-release capsules, usp are indicated for the treatment of hypertension. it may be used alone or in combination with other antihypertensive medications. diltiazem hydrochloride extended-release capsules, usp are indicated for the management of chronic stable angina and angina due to coronary artery spasm. diltiazem hydrochloride is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second-or third-degree av block except in the presence of a functioning ventricular pacemaker, (3) patients with hypotension (less than 90 mm hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.