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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.

1995

Cardiology/Vascular Diseases

Androderm (Testosterone Transdermal System); TheraTech; Treatment for primary and secondary hypogonadism, Approved on September 29, 1995

Corvert Injection (ibutilide fumarate injection); Pharmacia & Upjohn; Treatment for irregular contractions of the heart, Approved December 1995

Prinivil or Zestril (Lisinopril); Merck, Zeneca; Treatment for hypertension, heart failure, and acute myocardial infarction, Approved November 24, 1995

Toprol-XL (metoprolol succinate); AstraZeneca; For the treatment of hypertension, angina pectoris and heart failure, Approved January 1995

Dermatology

Renova (tretinoin emollient cream); Johnson & Johnson; Treatment for facial wrinkles, brown spots, and surface roughness associated with chronic sun exposure, Approved December 1995

Endocrinology

Amaryl (Glimepiride); Hoechst Marion Roussel; Treatment for type II diabetes, Approved December 1995

Androderm (Testosterone Transdermal System); TheraTech; Treatment for primary and secondary hypogonadism, Approved on September 29, 1995

Epivir (lamivudine); GlaxoSmithKline; Treatment used in combination with AZT for AIDS/HIV infection, Approved on November 17, 1995

Ethyol (amifostine); Alza; Treatment to reduce renal toxicity associated with chemotherapy in subjects with advanced ovarian cancer, Approved December 8, 1995

Fosamax (alendronate sodium); Merck; Treatment for osteoporosis in women after menopause and Paget's Disease of Bone, Approved on September 29, 1995

Invirase (saquinavir); Roche; Treatment for HIV/AIDS, Approved on December 7, 1995

Leukine (sargramostim); Immunex; Treatment for mobilizing peripheral blood progenitor cells for use after transplantation., Approved on November 24, 1995

Miacalcin (calcitonin-salmon) Nasal Spray; Sandoz Pharmaceuticals; Treatment for post-menopausal osteoporosis, Approved on August 17, 1995

Precose (acarbose); Bayer; Treatment for non-insulin-dependent diabetes mellitus, Approved September 6, 1995

Prempro & Premphase (conjugated estrogens/medroxyprogesterone acetate tablets); Wyeth; Treatment for postmenopausal hormone replacement, postmenopausal osteoporosis, Approved November 1995

Prinivil or Zestril (Lisinopril); Merck, Zeneca; Treatment for hypertension, heart failure, and acute myocardial infarction, Approved November 24, 1995

Western blot confirmatory device; Epitope; Confirmatory test for HIV, Approved in December 1995

Family Medicine

Amaryl (Glimepiride); Hoechst Marion Roussel; Treatment for type II diabetes, Approved December 1995

Avonex (Interferon Beta 1-A); Biogen IDEC; Treatment for multiple sclerosis, Recommended for Approval in December 1995

Caverject (alprostadil); Upjohn; Treatment for impotence, Approved on July 6, 1995

Cedax (ceftibuten); Schering-Plough; Treatment for chronic bronchitis, acute bacterial otitis media, pharyngitis/tonsillitis, Approved December 1995

Clarithromycin (Biaxin); Abbott Laboratories; Treatment for the prevention of disseminated Mycobacterium avium complex (MAC), Approved December 1995

Epivir (lamivudine); GlaxoSmithKline; Treatment used in combination with AZT for AIDS/HIV infection, Approved on November 17, 1995

Ethyol (amifostine); Alza; Treatment to reduce renal toxicity associated with chemotherapy in subjects with advanced ovarian cancer, Approved December 8, 1995

Femstat 3 (butoconazole nitrate 2%); Procter & Gamble, Roche; Over the counter treatment for vaginal yeast infections, Approved December 1995

Fosamax (alendronate sodium); Merck; Treatment for osteoporosis in women after menopause and Paget's Disease of Bone, Approved on September 29, 1995

Intron A (Interferon alfa-2b, recombinant); Schering-Plough; An adjuvant treatment to surgery in subjects at high risk for systemic recurrence of malignant melanoma, Approved December 1995

Invirase (saquinavir); Roche; Treatment for HIV/AIDS, Approved on December 7, 1995

Miacalcin (calcitonin-salmon) Nasal Spray; Sandoz Pharmaceuticals; Treatment for post-menopausal osteoporosis, Approved on August 17, 1995

Precose (acarbose); Bayer; Treatment for non-insulin-dependent diabetes mellitus, Approved September 6, 1995

Prempro & Premphase (conjugated estrogens/medroxyprogesterone acetate tablets); Wyeth; Treatment for postmenopausal hormone replacement, postmenopausal osteoporosis, Approved November 1995

Prinivil or Zestril (Lisinopril); Merck, Zeneca; Treatment for hypertension, heart failure, and acute myocardial infarction, Approved November 24, 1995

Self-examination breast pad; Inventive Products; Self-examination breast pad, Approved on December 22, 1995

Toprol-XL (metoprolol succinate); AstraZeneca; For the treatment of hypertension, angina pectoris and heart failure, Approved January 1995

Western blot confirmatory device; Epitope; Confirmatory test for HIV, Approved in December 1995

Zerit (stavudine); Bristol-Myers Squibb; Treatment for HIV-infected adults who are intolerant of approved therapies, Approved December 22, 1995

Immunology

Cedax (ceftibuten); Schering-Plough; Treatment for chronic bronchitis, acute bacterial otitis media, pharyngitis/tonsillitis, Approved December 1995

Clarithromycin (Biaxin); Abbott Laboratories; Treatment for the prevention of disseminated Mycobacterium avium complex (MAC), Approved December 1995

Epivir (lamivudine); GlaxoSmithKline; Treatment used in combination with AZT for AIDS/HIV infection, Approved on November 17, 1995

Intron A (Interferon alfa-2b, recombinant); Schering-Plough; An adjuvant treatment to surgery in subjects at high risk for systemic recurrence of malignant melanoma, Approved December 1995

Invirase (saquinavir); Roche; Treatment for HIV/AIDS, Approved on December 7, 1995

Valtrex (valacyclovir HCl); GlaxoSmithKline; Treatment for recurrent genital herpes, Approved December 1995

Western blot confirmatory device; Epitope; Confirmatory test for HIV, Approved in December 1995

Zerit (stavudine); Bristol-Myers Squibb; Treatment for HIV-infected adults who are intolerant of approved therapies, Approved December 22, 1995

Zyrtec (cetirizine HCl); Pfizer; Treatment for year-round allergies, seasonal allergic rhinitis, and chronic itching and hives, Approved December 1995

Infections and Infectious Diseases

Cedax (ceftibuten); Schering-Plough; Treatment for chronic bronchitis, acute bacterial otitis media, pharyngitis/tonsillitis, Approved December 1995

Clarithromycin (Biaxin); Abbott Laboratories; Treatment for the prevention of disseminated Mycobacterium avium complex (MAC), Approved December 1995

Epivir (lamivudine); GlaxoSmithKline; Treatment used in combination with AZT for AIDS/HIV infection, Approved on November 17, 1995

Invirase (saquinavir); Roche; Treatment for HIV/AIDS, Approved on December 7, 1995

Valtrex (valacyclovir HCl); GlaxoSmithKline; Treatment for recurrent genital herpes, Approved December 1995

Western blot confirmatory device; Epitope; Confirmatory test for HIV, Approved in December 1995

Zerit (stavudine); Bristol-Myers Squibb; Treatment for HIV-infected adults who are intolerant of approved therapies, Approved December 22, 1995

Zyrtec (cetirizine HCl); Pfizer; Treatment for year-round allergies, seasonal allergic rhinitis, and chronic itching and hives, Approved December 1995

Musculoskeletal

Fosamax (alendronate sodium); Merck; Treatment for osteoporosis in women after menopause and Paget's Disease of Bone, Approved on September 29, 1995

Miacalcin (calcitonin-salmon) Nasal Spray; Sandoz Pharmaceuticals; Treatment for post-menopausal osteoporosis, Approved on August 17, 1995

Prempro & Premphase (conjugated estrogens/medroxyprogesterone acetate tablets); Wyeth; Treatment for postmenopausal hormone replacement, postmenopausal osteoporosis, Approved November 1995

Nephrology

Caverject (alprostadil); Upjohn; Treatment for impotence, Approved on July 6, 1995

Neurology

Avonex (Interferon Beta 1-A); Biogen IDEC; Treatment for multiple sclerosis, Recommended for Approval in December 1995

Rilutek (riluzole); Rhone Poulenc Rorer; Treatment for amyotrophic lateral sclerosis (ALS), Approved December 1995

Obstetrics/Gynecology (Women’s Health)

Ethyol (amifostine); Alza; Treatment to reduce renal toxicity associated with chemotherapy in subjects with advanced ovarian cancer, Approved December 8, 1995

Femstat 3 (butoconazole nitrate 2%); Procter & Gamble, Roche; Over the counter treatment for vaginal yeast infections, Approved December 1995

Fosamax (alendronate sodium); Merck; Treatment for osteoporosis in women after menopause and Paget's Disease of Bone, Approved on September 29, 1995

Miacalcin (calcitonin-salmon) Nasal Spray; Sandoz Pharmaceuticals; Treatment for post-menopausal osteoporosis, Approved on August 17, 1995

Prempro & Premphase (conjugated estrogens/medroxyprogesterone acetate tablets); Wyeth; Treatment for postmenopausal hormone replacement, postmenopausal osteoporosis, Approved November 1995

Self-examination breast pad; Inventive Products; Self-examination breast pad, Approved on December 22, 1995

Oncology

Ethyol (amifostine); Alza; Treatment to reduce renal toxicity associated with chemotherapy in subjects with advanced ovarian cancer, Approved December 8, 1995

Intron A (Interferon alfa-2b, recombinant); Schering-Plough; An adjuvant treatment to surgery in subjects at high risk for systemic recurrence of malignant melanoma, Approved December 1995

Leukine (sargramostim); Immunex; Treatment for mobilizing peripheral blood progenitor cells for use after transplantation., Approved on November 24, 1995

Self-examination breast pad; Inventive Products; Self-examination breast pad, Approved on December 22, 1995

Otolaryngology (Ear, Nose, Throat)

Cedax (ceftibuten); Schering-Plough; Treatment for chronic bronchitis, acute bacterial otitis media, pharyngitis/tonsillitis, Approved December 1995

Pulmonary/Respiratory Diseases

Cedax (ceftibuten); Schering-Plough; Treatment for chronic bronchitis, acute bacterial otitis media, pharyngitis/tonsillitis, Approved December 1995

Zyrtec (cetirizine HCl); Pfizer; Treatment for year-round allergies, seasonal allergic rhinitis, and chronic itching and hives, Approved December 1995

Urology

Caverject (alprostadil); Upjohn; Treatment for impotence, Approved on July 6, 1995