| Reference Listed Drug | NDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
|---|---|---|---|---|---|
| Avodart | GlaxoSmithKline | Dutasteride Soft Gelatin Capsules | Marksans | Indicated for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate. | 4/7/2017 |
| Nasonex | Merck Sharp Dohme | Mometasone Furoate Monohydrate Nasal Spray | Amneal | Indicated to prevent and treat seasonal and year-round allergy symptoms (such as stuffy/runny nose, itching, and sneezing). | 4/11/2017 |
| Lozol | Aventis | Indapamide Tablets | ANI | Indicated for treatment of hypertension and swelling associated with congestive heart failure. | 4/19/2017 |
| Prometrium | AbbVie | Progesterone Capsules | Dr. Reddy's | Indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea. | 4/21/2017 |
| Vytorin | Merck Sharp & Dohme | Ezetimibe / Simvastatin | Impax | Indicated for the treatment of high cholesterol. | 4/26/2017 |
| Vytorin | Merck Sharp & Dohme | Ezetimibe / Simvastatin | Teva | Indicated, along with diet, to lower the level of "bad" cholesterol; increase the level of "good" cholesterol; and lower the level of fat in blood. | 4/26/2017 |
| Benicar | Daiichi Sankyo | Olmesartan Medoxomil Tablets | Aurobindo | Indicated for treatment of hypertension. | 5/1/2017 |
| Benicar HCT | Daiichi Sankyo | Olmesartan Medoxomil / Hydrochlorothiazide Tablets | Aurobindo | Indicated for treatment of hypertension. | 5/1/2017 |
| Glumetza | Valeant | Metformin Hydrochloride ER Tablets | Teva | Indicated, along with diet and exercise, to help control high blood sugar in adults with type 2 diabetes mellitus. | 5/15/2017 |
| Clolar | Genzyme | Clofarabine Injection | Fresenius Kabi USA | Indicated for treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regiments. | 5/16/2017 |
| Doxil | ALZA | Doxorubicin Hydrochloride Liposome Injection | Dr. Reddy's | Indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy; treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. | 5/17/2017 |
| Edecrin | Aton | Ethacrynic Acid Tablets | West-Ward Pharmaceuticals | Indicated for the treatment of edema when an agent with greater diuretic potential than those commonly employed is required. | 5/17/2017 |
| Azor | Daiichi Sankyo | Amlodipine / Olmesartan Medoxomil Tablets | Aurobindo | Indicated for treatment of hypertension. | 5/22/2017 |
| Namenda | Forest Labs | Memantine Hydrochloride Tablets | Strides | Indicated for treatment of moderate to severe Alzheimer-type dementia. | 5/24/2017 |
| Strattera | Eli Lilly | Atomoxetine Capsules | Aceto | Indicated for treatment of Attention-Deficit Hyperactivity Disorder. | 5/31/2017 |
| Motrin IB (OTC) | Johnson and Johnson | Ibuprofen Tablets (marketed under OTC brand Nuprin) | Strides | Indicated for the treatment of pain relief from various conditions such as headache, dental pain, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu. | 6/1/2017 |
| Azilect | Teva | Rasagiline Tablets | Mylan | Indicated for treatment of Parkinson's disease. | 6/2/2017 |
| Reclast | Novartis | Zoledronic Acid Injection | Mylan | Indicated for the treatment of Paget's disease of bone in men and women. | 6/2/2017 |
| Angiomax | The Medicines Company | Bivalirudin for Injection | Dr. Reddy's | Indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty. | 6/6/2017 |
| Pataday | Novartis | Olopatadine Hydrochloride Ophthalmic Solution 0.2% | Teva | Indicated for treatment of ocular itching associated with allergic conjunctivitis. | 6/9/2017 |
| Percocet | Vintage | Oxycodone / Acetaminophen Tablets | Camber | Indicated for treatment of moderate to moderately severe pain. | 6/12/2017 |
| Norpramin | U.S. Pharmaceutical Holdings II | Desipramine IR Tablets | Heritage | Indicated for the treatment of depression. | 6/12/2017 |
| Pataday | Alcon | Olopatadine Hydrochloride Ophthalmic Solution 0.2% | Sandoz | Indicated for treatment of ocular itching associated with allergic conjunctivitis. | 6/12/2017 |
| Zetia | Merck Sharp & Dohme | Ezetimibe Tablets | Teva | Indicated to lower levels of total cholesterol and low-density lipoprotein cholesterol in the blood. | 6/12/2017 |
| Zetia | Merck Sharp & Dohme | Ezetimibe Tablets | Amneal | Indicated to lower levels of total cholesterol and low-density lipoprotein cholesterol in the blood. | 6/15/2017 |
| Wellbutrin XL Tablets | Valeant | Bupropion Hydrochloride ER Tablets | Lupin | Indicated for the treatment of Major Depressive Disorder and prevention of Seasonal Affective Disorder in adults. | 6/15/2017 |
| Acticlate | Aqua Pharmaceuticals | Doxycycline Hyclate IR Tablets | Mayne | Indicated for treatment of a number of infections, including adjunctive therapy in severe acne. | 6/15/2017 |
| Hycodan | Endo | Hydrocodone Bitartrate / Homatropine Methylbromide Oral Solution | Perrigo | Indicated for the symptomatic relief of cough in adults and children 6 years of age and older. | 6/19/2017 |
| Glucotrol XL | Pfizer | Elipizide ER Tablets | Aceto | Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. | 6/20/2017 |
| Micardis | Boehringer Ingelheim | Telmisartan Tablets | Camber | Indicated to treat high blood pressure (hypertension). | 6/21/2017 |
| Derma-Smoothe/FS Scalp Oil / Derma-Smoothe/FS Body Oil | Hill Laboratories | Fluocinolone Acetonide Scalp Oil / Fluocinolone Acetonide Topical Oil, 0.01% | Perrigo | Indicated for the topical treatment of atopic dermatitis in adult patients and the topical treatment of moderate to severe atopic dermatitis in pediatric patients 3 months and older for up to four weeks. | 6/21/2017 |
| Topicort | Taro | Desoximetasone Cream USP, 0.05% / Desoximetasone Cream USP, 0.25% | Lupin | Indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. | 6/22/2017 |
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