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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.
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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
