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Generic Launches

Reference Listed Drug NDA Holder Generic Drug Name ANDA
Applicant(s)
Indication Launch Date
Exforge Novartis Amlodipine / Valsartan Lupin Pharmaceuticals treatment of hypertension and to lower blood pressure 4/1/2015
FemHRT Warner Chilcott Norethindrone Acetate / Ethinyl Estradiol Glenmark Generics moderate to severe vasomotor symptoms due to menopause and for the prevention of postmenopausal osteoporosis in women at significant risk of osteoporosis 4/7/2015
Generess Fe Tablets Warner Chilcott Norethindrone / Ethinyl Estradiol / Ferrous Fumarate Mylan prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception 4/7/2015
Exalgo Mallinckrodt Hydromorphone Extended-Release Tablets Perrigo treatment of chronic pain in opioid-tolerant patients requiring continuous around-the-clock opioid analgesia for an extended amount of time 4/8/2015
Lybrel Wyeth Levonorgestrel / Ethinyl Estradiol Tablets USP Glenmark Generics prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception 4/10/2015
Kenalog Topical Spray Sun Pharma Triamcinolone Acetonide Topical Aerosol Perrigo relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses 4/16/2015
Abilify Otsuka Pharmaceutical Aripiprazole Teva Pharmaceutical Industries treatment of schizophrenia and for the acute treatment of manic and mixed episodes associated with bipolar I disorder 4/28/2015
Seasonale Teva Women's Health Levonorgestrel / Ethinyl Estradiol Tablets Mylan prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception 5/5/2015
Pulmicort Respules AstraZeneca Budesonide Inhalation Suspension Allergan maintenance medicine to control and prevent asthma symptoms in children ages 12 months to 8 years 5/7/2015
Lotronex Prometheus Laboratories Alosetron Hydrochloride Tablets Roxane Laboratories for some women with severe Irritable Bowel Syndrome (IBS) 5/21/2015
DDAVP Ferring Pharmaceuticals Desmopressin Acetate Tablets Glenmark Pharmaceuticals antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of temporary polyuria and polydipsia following head trauma or surgery in the pituitary region 5/29/2015
Lomedia 24 Fe Amneal Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate Teva for prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception 5/29/2015
Actonel Actavis Risedronate Sodium Tablets Teva help increase bone mass and help reduce the chance of having a spinal or non-spinal fracture (break) and are also used to treat or prevent osteoporosis in either men or women who are taking corticosteroid medicines, and to treat Paget's disease of the bone 6/1/2015
Intuniv Shire Guanfacine Hydrochloride Extended-Release Tablets Mylan treatment of Attention Deficit Hyperactivity Disorder (ADHD) 6/2/2015
Seasonique Teva Levonorgestrel / Ethinyl Estradiol Tablets Mylan (Famy Care) prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception 6/2/2015
Intuniv Shire Guanfacine Hydrochloride Extended-Release Tablets Teva treatment of Attention Deficit Hyperactivity Disorder (ADHD) 6/2/2015
Intuniv Shire Guanfacine Hydrochloride Extended-Release Tablets Sandoz treatment of Attention Deficit Hyperactivity Disorder (ADHD) 6/4/2015
Dovonex Cream Leo Pharma Calcipotriene Cream Glenmark Pharmaceuticals treatment for psoriasis 6/11/2015
Seasonale Teva Women's Health Levonorgestrel / Ethinyl Estradiol Tablets Glenmark Pharmaceuticals prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception 6/15/2015
Copaxone Teva Glatiramer Acetate Sandoz treatment for relapsing forms of Multiple Sclerosis 6/18/2015

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