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FDA Approved Drugs

The following database contains a listing of drugs approved by the Food and Drug Administration (FDA) for sale in the United States. Drug information typically includes the drug name, approval status, indication of use, and clinical trial results. Review descriptions for our medical therapeutic area list to help assist in your search.

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Find out more about the types of drugs included in this listing.

2000

Cardiology/Vascular Diseases

Angiomax (bivalirudin); The Medicines Company; For patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA), Approved December 2000

Argatroban Injection; Texas Biotechnology Corporation, SmithKline Beecham; Anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia., Approved June 2000

Atacand (candesartan cilexetil); AstraZeneca; For the treatment of hypertension, Approved September 2000

Betapace AF Tablet; Berlex Laboratories; For treatment of the irregular heartbeats in patients with atrial fibrillation, Approved February 2000

Diltiazem HCL, Extended-Release Capsules; Biovail Laboratories; For the reduction of high blood pressure, Approved January 2000

Innohep (tinzaparin sodium) injectable; DuPont Merck Pharmaceutical Company; For the treatment of acute symptomatic deep vein thrombosis, Approved July 2000

Lescol XL (fluvastatin sodium) tablet, extended release; Novartis; For the use as an adjunct to diet to reduce elevated total cholesterol, Approved October 2000

Micardis HCT (telmisartan and hydrochlorothiazide); Boehringer Ingelheim; For the treatment of hypertension, Approved November 2000

Nitrostat (nitroglycerin) Tablets; Parke-Davis; For the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease., Approved May 2000

Dermatology

Benzamycin (erythromycin 3%-benzoyl peroxide 5% topical gel); Dermik Laboratories; For the topical treatment of acne vulgaris, Approved November 2000

Cefazolin and Dextrose USP; B Braun Medical; Respiratory tract infections, Approved July 2000

Chloraprep (chlorhexidine gluconate); MEDI FLEX HOSP PRODUCTS; For use as a patient preoperative skin preparation, Approved July 2000

Clindamycin phosphate topical gel; Target Research Associates; For once a day treatment of acne vulgaris, Approved November 2000

Lamisil (terbinafine hydrochloride) Solution, 1%; Novartis; For the treatment of athlete's foot, jock itch and ringworm, Approved March 2000

Protopic (tacrolimus) ointment; Fujisawa Healthcare; For short-term and intermittent long-term treatment of moderate to severe atopic dermatitis, Approved December 2000

Skin Exposure Reduction Paste Against Chemical Warfare Agents (SERPACWA); U.S. Army Medical Research, Material Command; To reduce absorption of chemical warfare agents through the skin, Approved February 2000

Endocrinology

Activella (Estradiol/Norethindrone Acetate) Tablets; Novo Nordisk; Combination hormone replacement therapy for the prevention of osteoporosis and other symptoms associated w/postmenopause, Approved April 2000

AndroGel testosterone gel; Unimed Pharmaceuticals; For testosterone replacement therapy in males with testosterone deficiency, Approved February 2000

Atacand (candesartan cilexetil); AstraZeneca; For the treatment of hypertension, Approved September 2000

Cetrotide; Asta Medica; For the prevention of premature ovulation in women undergoing controlled ovarian stimulation, Approved August 2000

Diltiazem HCL, Extended-Release Capsules; Biovail Laboratories; For the reduction of high blood pressure, Approved January 2000

Hectorol (Doxercalciferol) Injection; Bone Care International; To reduce iPTH levels in management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis, Approved April 2000

Lantus (insulin glargine [rDNA origin] injection); Sanofi-aventis; For adults and children w/Type 1 diabetes, or adults w/Type 2 diabetes requiring basal insulin to control hyperglycemia, Approved April 2000

Lantus (insulin glargine [rDNA origin] injection); Sanofi-aventis; For the treatment of type I and type II diabetes mellitus in adults and pediatrics, Approved April 2000

Lescol XL (fluvastatin sodium) tablet, extended release; Novartis; For the use as an adjunct to diet to reduce elevated total cholesterol, Approved October 2000

Micardis HCT (telmisartan and hydrochlorothiazide); Boehringer Ingelheim; For the treatment of hypertension, Approved November 2000

Mirena (levonorgestrel-releasing intrauterine system); Berlex Laboratories; Hormone-releasing system for intrauterine contraception, Approved December 2000

NovoLog (insulin aspart); Novo Nordisk; An insulin analogue for the treatment of diabetes mellitus., Approved June 2000

Ovidrel (gonadotropin, chorionic human recombinant); Serono Laboratories; For the induction of final follicular maturation and early luteinization in infertile women, Approved September 2000

Trelstar Depot (triptorelin pamoate); Debio Rechereche Pharmaceutique, Target Research Associates; For the palliative treatment of advanced prostate cancer, Approved June 2000

Viadur (leuprolide acetate implant); Alza; For pain relief in men with advanced prostate cancer, Approved March 2000

Vivelle (estradiol transdermal system); Novartis; For the prevention of postmenopausal osteoporosis, Approved August 2000

Family Medicine

Atacand (candesartan cilexetil); AstraZeneca; For the treatment of hypertension, Approved September 2000

Benzamycin (erythromycin 3%-benzoyl peroxide 5% topical gel); Dermik Laboratories; For the topical treatment of acne vulgaris, Approved November 2000

Betaxon; Alcon; For lowering IOP in patients with chronic open-angle glaucoma or ocular hypertension, Approved February 2000

Biaxin XL (clarithromycin extended-release tablets); Abbott Laboratories; For Acute Bacterial Exacerbation of Chronic Bronchitis (AECB) and Acute Maxillary Sinusitis, Approved March 2000

Cefazolin and Dextrose USP; B Braun Medical; Respiratory tract infections, Approved July 2000

Children's Motrin Cold; McNeil Consumer Products; For temporary relief of the common cold, Approved August 2000

Clindamycin phosphate topical gel; Target Research Associates; For once a day treatment of acne vulgaris, Approved November 2000

Colazal (balsalazide disodium); Salix Pharmaceuticals; Mild to moderately active ulcerative colitis, Approved July 2000

Concerta; Alza; For the treatment of Attention Deficit Hyperactivity Disorder, Approved August 2000

Depakote ER (divalproex sodium); Abbott Laboratories; For the prophylaxis (prevention) of migraine headaches in adults, Approved August 2000

Diltiazem HCL, Extended-Release Capsules; Biovail Laboratories; For the reduction of high blood pressure, Approved January 2000

Exelon (rivastigmine tartrate); Novartis; Indicated for the treatment of mild to moderate dementia of the Alzheimer's type, Approved April 2000

Kaletra Capsules and Oral Solution; Abbott Laboratories; For the treatment of HIV-1 infection, Approved September 2000

Lamisil (terbinafine hydrochloride) Solution, 1%; Novartis; For the treatment of athlete's foot, jock itch and ringworm, Approved March 2000

Lantus (insulin glargine [rDNA origin] injection); Sanofi-aventis; For the treatment of type I and type II diabetes mellitus in adults and pediatrics, Approved April 2000

Lescol XL (fluvastatin sodium) tablet, extended release; Novartis; For the use as an adjunct to diet to reduce elevated total cholesterol, Approved October 2000

Lotrisone (clotrimazole/betamethasone diproprionate) lotion; Schering-Plough; For the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis, Approved December 2000

Lotronex (alosetron HCL) Tablets; GlaxoSmithKline; Indicated for Irritable Bowel Syndrome (IBS) in females with diarrhea-predominant IBS, Approved February 2000

Micardis HCT (telmisartan and hydrochlorothiazide); Boehringer Ingelheim; For the treatment of hypertension, Approved November 2000

Mobic (meloxicam) Tablets; Boehringer Ingelheim; For relief of the signs and symptoms of osteoarthritis, Approved April 2000

Neurontin (gabapentin) oral solution; Parke-Davis; Treatment of partial seizures in adults with epilepsy, Approved March 2000

Neurontin (gabapentin) oral solution; Parke-Davis; For the treatment of partial seizures in pediatric patients three years of age and older, Approved October 2000

Nitrostat (nitroglycerin) Tablets; Parke-Davis; For the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease., Approved May 2000

Novantrone (mitoxantrone hydrochloride); Immunex; For reducing neurologic disability and/or the frequency of clinical relapses in patients with multiple sclerosis, Approved October 2000

NovoLog (insulin aspart); Novo Nordisk; An insulin analogue for the treatment of diabetes mellitus., Approved June 2000

Ovidrel (gonadotropin, chorionic human recombinant); Serono Laboratories; For the induction of final follicular maturation and early luteinization in infertile women, Approved September 2000

Pepcid Complete; Merck; For use in the relief of heartburn associated with acid indigestion and sour stomach, Approved October 2000

Protonix (pantoprazole sodium) Delayed-Release Tablets; Wyeth; For treatment of erosive esophagitis, Approved February 2000

Protopic (tacrolimus) ointment; Fujisawa Healthcare; For short-term and intermittent long-term treatment of moderate to severe atopic dermatitis, Approved December 2000

Renagel (sevelamer hydrochloride); Genzyme; For the control of serum phosphorus in patients with chronic kidney disease on dialysis, Approved July of 2000

Rescula (unoprostone isopropyl ophthalmic solution) 0.15%; Ciba Vision; For the treatment of open-angle glaucoma or ocular hypertension, Approved August 2000

Trelstar Depot (triptorelin pamoate); Debio Rechereche Pharmaceutique, Target Research Associates; For the palliative treatment of advanced prostate cancer, Approved June 2000

Trileptal (oxcarbazepine) Tablets; Novartis; Approved for use as adjunctive therapy in the treatment of partial seizures in children (monotherapy for adults), Approved January 2000

Trizivir (abacavir sulfate; lamivudine; zidovudine AZT) Tablet; GlaxoSmithKline; For the treatment of HIV-1 infection, Approved November 2000

Venofer (iron sucrose injection); Luitpold Pharmaceuticals; For the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis, Approved November 2000

Viadur (leuprolide acetate implant); Alza; For pain relief in men with advanced prostate cancer, Approved March 2000

Vivelle (estradiol transdermal system); Novartis; For the prevention of postmenopausal osteoporosis, Approved August 2000

Zonegran (zonisamide) Capsules; Dainippon Pharmaceutical; Adjunctive therapy for treatment of partial seizures in adults with epilepsy, Approved March 2000

Gastroenterology

Colazal (balsalazide disodium); Salix Pharmaceuticals; Mild to moderately active ulcerative colitis, Approved July 2000

Lotronex (alosetron HCL) Tablets; GlaxoSmithKline; Indicated for Irritable Bowel Syndrome (IBS) in females with diarrhea-predominant IBS, Approved February 2000

Pepcid Complete; Merck; For use in the relief of heartburn associated with acid indigestion and sour stomach, Approved October 2000

Protonix (pantoprazole sodium) Delayed-Release Tablets; Wyeth; For treatment of erosive esophagitis, Approved February 2000

Visicol Tablet; Inkine Pharmaceutical; For cleansing of the bowel as a preparation for colonoscopy, in adults 18 years of age and older, Approved September 2000

Genetic Disease

Kogenate FS (Antihemophilic Factor Recombinant); Bayer; For the treatment of hemophilia A, Approved June 2000

Neurontin (gabapentin) oral solution; Parke-Davis; Treatment of partial seizures in adults with epilepsy, Approved March 2000

Trileptal (oxcarbazepine) Tablets; Novartis; Approved for use as adjunctive therapy in the treatment of partial seizures in children (monotherapy for adults), Approved January 2000

Zonegran (zonisamide) Capsules; Dainippon Pharmaceutical; Adjunctive therapy for treatment of partial seizures in adults with epilepsy, Approved March 2000

Hematology

Innohep (tinzaparin sodium) injectable; DuPont Merck Pharmaceutical Company; For the treatment of acute symptomatic deep vein thrombosis, Approved July 2000

Kogenate FS (Antihemophilic Factor Recombinant); Bayer; For the treatment of hemophilia A, Approved June 2000

Renagel (sevelamer hydrochloride); Genzyme; For the control of serum phosphorus in patients with chronic kidney disease on dialysis, Approved July of 2000

Venofer (iron sucrose injection); Luitpold Pharmaceuticals; For the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis, Approved November 2000

Immunology

ABREVA (docosanol); AVANIR PHARMACEUTICALS; Cold sore/fever blister, Approved July 2000

Biaxin XL (clarithromycin extended-release tablets); Abbott Laboratories; For Acute Bacterial Exacerbation of Chronic Bronchitis (AECB) and Acute Maxillary Sinusitis, Approved March 2000

Cefazolin and Dextrose USP; B Braun Medical; Respiratory tract infections, Approved July 2000

Children's Motrin Cold; McNeil Consumer Products; For temporary relief of the common cold, Approved August 2000

Evoxac; SnowBrand Pharmaceuticals; For the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome, Approved January 2000

Kaletra Capsules and Oral Solution; Abbott Laboratories; For the treatment of HIV-1 infection, Approved September 2000

Lamisil (terbinafine hydrochloride) Solution, 1%; Novartis; For the treatment of athlete's foot, jock itch and ringworm, Approved March 2000

Malarone (atovaquone; proguanil hydrochloride) Tablet; GlaxoSmithKline; For the treatment and prevention of Plasmodium falciparum malaria, Approved July 2000

Rapamune (sirolimus) Tablets; Wyeth; For treatment of kidney rejection, Approved August 2000

Rid Mousse; Soltec Research; For the treatment of head, pubic (crab), and body lice, Approved March 2000

Tri-Nasal Spray (triamcinolone acetonide spray); Muro Pharmaceutical; For treatment of nasal symptoms of allergic rhinitis in adults and children age 12 or older, Approved February 2000

Trivagizole 3 (clotrimazole) Vaginal Cream; Taro Pharmaceuticals; For the treatment of vaginal yeast infections, Approved April 2000

Trizivir (abacavir sulfate; lamivudine; zidovudine AZT) Tablet; GlaxoSmithKline; For the treatment of HIV-1 infection, Approved November 2000

Infections and Infectious Diseases

ABREVA (docosanol); AVANIR PHARMACEUTICALS; Cold sore/fever blister, Approved July 2000

Cefazolin and Dextrose USP; B Braun Medical; Respiratory tract infections, Approved July 2000

Children's Motrin Cold; McNeil Consumer Products; For temporary relief of the common cold, Approved August 2000

Kaletra Capsules and Oral Solution; Abbott Laboratories; For the treatment of HIV-1 infection, Approved September 2000

Lamisil (terbinafine hydrochloride) Solution, 1%; Novartis; For the treatment of athlete's foot, jock itch and ringworm, Approved March 2000

Lotronex (alosetron HCL) Tablets; GlaxoSmithKline; Indicated for Irritable Bowel Syndrome (IBS) in females with diarrhea-predominant IBS, Approved February 2000

Tri-Nasal Spray (triamcinolone acetonide spray); Muro Pharmaceutical; For treatment of nasal symptoms of allergic rhinitis in adults and children age 12 or older, Approved February 2000

Trizivir (abacavir sulfate; lamivudine; zidovudine AZT) Tablet; GlaxoSmithKline; For the treatment of HIV-1 infection, Approved November 2000

Musculoskeletal

Mobic (meloxicam) Tablets; Boehringer Ingelheim; For relief of the signs and symptoms of osteoarthritis, Approved April 2000

Myobloc; Elan Pharmaceuticals; Injectable solution for the treatment of abnormal head position and neck pain associated with cervical dystonia, Approved December 2000

Nephrology

Cefazolin and Dextrose USP; B Braun Medical; Respiratory tract infections, Approved July 2000

Detrol LA (tolterodine tartrate); Pharmacia & Upjohn; For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency, Approved December 2000

Rapamune (sirolimus) Tablets; Wyeth; For treatment of kidney rejection, Approved August 2000

Renagel (sevelamer hydrochloride); GelTex Pharmaceuticals; For the reduction of serum phosphorus in patients with end-stage renal disease (ESRD), Approved July 2000

Renagel (sevelamer hydrochloride); Genzyme; For the control of serum phosphorus in patients with chronic kidney disease on dialysis, Approved July of 2000

Trelstar Depot (triptorelin pamoate); Debio Rechereche Pharmaceutique, Target Research Associates; For the palliative treatment of advanced prostate cancer, Approved June 2000

Venofer (iron sucrose injection); Luitpold Pharmaceuticals; For the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis, Approved November 2000

Viadur (leuprolide acetate implant); Alza; For pain relief in men with advanced prostate cancer, Approved March 2000

Neurology