| Reference Listed Drug | NDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
|---|---|---|---|---|---|
| Colcrys | Takeda | Colchicine Tablets | Endo | indicated for prophylaxis and treatment of gout flares in adults and Familial Mediterranean Fever (FMF) in adults and children 4 years or older | 7/2/2018 |
| Exelon Patch | Novartis | Rivastigmine Transdermal System | Mylan | indicated for the treatment of dementia associated with mild, moderate and severe Alzheimer's Disease and the treatment of mild to moderate dementia associated with Parkinson's Disease | 7/9/2018 |
| Uceris | Santarus and Valeant Pharmaceuticals | Budesonide Extended-Release Tablets | Teva | indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis | 7/9/2018 |
| Plaquenil | Concordia | Hydroxychloroquine Sulfate Tablets | Dr. Reddy's Labs | indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax; the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported; the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; the treatment of acute and chronic rheumatoid arthritis in adults | 7/11/2018 |
| Kapvay | Concordia | Clonidine Extended-Release Tablets | Mayne Pharma | indicated for the treatment of attention deficit hyperactivity disorder as monotherapy or as adjunct to stimulant medications |
7/16/2018 |
| Blenoxane | Bristol-Myers Squibb | Bleomycin for Injection | Hikma | indicated for the management of certain types of Squamous Cell Carcinoma, Lymphomas, Testicular Carcinoma, and Malignant Pleural Effusion | 7/18/2018 |
| Nexium 24HR Capsules | AstraZeneca | Esomeprazole Magnesium Delayed-Release Capsules | Dr. Reddy's Labs | indicated for the treatment of frequent heartburn occurring two or more days a week in adults | 7/20/2018 |
| Potassium Chloride Oral Solution | Genus LifeSciences | Potassium Chloride Oral Solution | Amneal | indicated for the treatment or prevention of low levels of potassium in the blood | 7/23/2018 |
| Efudex | ICN Pharmaceuticals | Fluorouracil Cream | Mayne Pharma | indicated for the treatment of multiple actinic or solar keratoses, and for the treatment of superficial basal cell carcinomas when conventional methods of treatment are impractical | 7/23/2018 |
| Glumetza HCI ER Tablets | Santarus | Metformin HCl Extended-Release Tablets | Sun | indicated for the treatment of patients with type 2 diabetes; controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems | 7/25/2018 |
| Invanz | Merck Sharpe & Dohme | Ertapenem for Injection | Endo | indicated for the treatment of infections and it can also prevent infections after colon and rectal surgery | 7/27/2018 |
| Topicort Topical Spray | Taro | Desoximetasone Topical Spray | Lupin | indicated for the treatment of plaque psoriasis in patients 18 years of age or older | 7/27/2018 |
| Voltaren Gel | GlaxoSmithKline | Diclofenac Sodium Topical Gel, 1% | Cipla | indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands | 8/7/2018 |
| Xeloda | Genentech | Capecitabine | MSN Labs / Cipla | indicated as a single agent for adjuvant treatment in patients with Dukes C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred, and also indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy | 8/10/2018 |
| Adcirca | Eli Lilly | Tadalafil Tablets | Mylan | indicated for the treatment of pulmonary arterial hypertension to improve exercise ability | 8/13/2018 |
| Temovate | Fougera Pharmaceuticals | Clobetasol Propionate Cream | Lupin | indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses | 8/21/2018 |
| Beyaz | Bayer | Drospirenone / Ethinyl Estradiol / Levomefolate Calcium Tablets | Lupin | indicated for the treatment as an oral contraceptive for birth control | 8/27/2018 |
| Klor-Con ER Tablets | Upsher-Smith Labs | Potassium Chloride Extended-Release Tablets | Strides | indicated for the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis | 9/5/2018 |
| Bloxiverz | Avadel Legacy Pharmaceuticals | Neostigmine Methylsulfate Injection | Dr. Reddy's Labs | indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery | 9/12/2018 |
| Brevibloc | Baxter | Esmolol HCl in Sodium Chloride Injection | Mylan | indicated for the short-term treatment of control of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia and control of perioperative tachycardia and hypertension | 9/13/2018 |
| Ampyra | Acorda | Dalfampridine Extended-Release Tablets | Mylan | indicated to improve walking in adult patients with multiple sclerosis | 9/13/2018 |
| Norvir | AbbVie | Ritonavir Tablets | Camber Pharmaceuticals | indicated for the treatment of HIV | 9/18/2018 |
| Albenza | Impax Labs | Albendazole Tablets | Cipla | indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia sodium and cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus | 9/22/2018 |
| Cialis | Eli Lilly | Tadalafil Tablets | Teva | indicated for the treatment of erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and both ED and the signs and symptoms of BPH (ED/BPH) | 9/27/2018 |
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