| Reference Listed Drug | NDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
|---|---|---|---|---|---|
| Femhrt | Warner Chilcott | Norethindrone Acetate and Ethinyl Estradiol Tablets | Lupin | indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and prevention of postmenopausal osteoporosis | 4/5/2016 |
| Epivir | ViiV Healthcare | Lamivudine Tablets | Mylan | indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection | 4/6/2016 |
| Lopressor | Novartis | Metoprolol Tartrate Tablets | Mylan | indicated for the treatment of hypertension | 4/11/2016 |
| Glucerna Asceptic Adult Nutritional Shake (OTC) | Abbott Laboratories | Glucerna Asceptic Adult Nutritional Shake (OTC) | Perrigo | nutritional shake for people with diabetes | 4/12/2016 |
| Zyvox | Pfizer | Linezolid Injection in Freeflex bags | Fresenius Kabi USA | indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial and Community-acquired pneumonia, Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, Uncomplicated skin and skin structure infections, and Vancomycin-resistant Enterococcus faecium infections | 4/21/2016 |
| BenzaClin Pump Topical Gel | Valeant Pharmaceutical | Clindamycin Phosphate 1% / Benzoyl Peroxide 5% | Perrigo | indicated for the topical treatment of acne vulgaris | 5/2/2016 |
| Mucinex DM ER Tablets (OTC) | Reckitt Benckiser | Guaifenesin / Dextromethorphan Hydrobromide ER Tablets (OTC) | Perrigo | indicated to control coughs and to break up mucus, making coughs more productive | 5/3/2016 |
| Apresoline | Novartis | Hydralazine Hydrochloride Injection | Mylan | treatment of severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure | 5/5/2016 |
| Lipofen | Cipher Pharmaceuticals | Fenofibrate Capsules | ANI Pharmaceuticals | indicated as an adjunct to diet: to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia and for treatment of adult patients with severe hypertriglyceridemia | 5/9/2016 |
| Frova | Endo Pharms | Frovatriptan Succinate Tablets | Mylan | treat acute migraine headaches in adults | 5/12/2016 |
| Rowasa | Alaven Pharmaceuticals | Mesalamine rectal suspension enema | ANI Pharmaceuticals Inc. | indicated for treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis | 5/16/2016 |
| Apresazide | Novartis | Hydralazine Hydrochloride Injection | Mylan | indicated for treatment of severe essential hypertension when the oral version of the drug cannot be given and there is in urgent need to lower blood pressure | 5/16/2016 |
| Doryx | Mayne | Doxycycline Hyclate Delayed-Release (DR) Tablets, 200 mg. | Mylan | indicated as adjunctive therapy for severe acne | 5/23/2016 |
| Flonase (OTC) | GlaxoSmithKline | Fluticasone 50 MCG Spray (OTC) | Hikma | indicated for the temporary relief of hay fever or for the upper respiratory allergies in adult and pediatric patients 4 years of age and older | 5/31/2016 |
| Flonase (OTC) | GlaxoSmithKline | Fluticasone Propionate Nasal Spray (OTC) | Perrigo | indicated for the temporary relief of hay fever or other upper respiratory allergies in adult and pediatric patients 4 years of age and older | 5/31/2016 |
| Doxteric | Mayne | Doxycycline Hyclate Delayed-Release (DR) Tablets, 50 mg. | Mylan | indicated as adjunctive therapy for severe acne | 6/1/2016 |
| Nuvigil | Cephalon | Armodafinil Tablets | Mylan | used to improve wakefulness in adults with excessive sleepiness associated with obstructive sleep apnea, narcolepsy or shift-work disorder | 6/1/2016 |
| Rythmol SR | GlaxoSmithKline | Propafenone Hydrochloride ER Capsules | Mylan | indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease | 6/2/2016 |
| Vidaza | Celgene | Azacitidine for Injection | Mylan | indicated for the treatment of the five French-American-British (FAB) subtypes of myelodysplastic syndrome, a blood cell disorder that can occur as a result of cancer treatments or can progress to leukemia | 6/2/2016 |
| Cleocin | Pharmacia and Upjohn | Clindamycin Palmitate Hydrochloride for Oral Solution | Mylan | indicated for treatment of serious infections caused by susceptible anaerobic bacteria and susceptible strains of streptococci, pneumococci and staphylococci when less toxic alternatives are inappropriate | 6/3/2016 |
| OxyIR | Purdue Pharma | Oxycodone HCI Capsules | ANI Pharmaceuticals | indicated for the management of moderate to severe acute and chronic pain where the use of an opioid analgesic is appropriate | 6/13/2016 |
| Namenda | Forest Laboratories | Memantine Hydrochloride Tablets | Ajanta Pharma | anti-dementia drug | 6/14/2016 |
| Avodart | GlaxoSmithKline | Dutasteride Capsules | Mylan | indicated as monotherapy for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for BPH-related surgery | 6/24/2016 |
| Imitrex | GlaxoSmithKline | Sumatriptan Injection | Teva / Antares Pharma | treat acute migraine with or without aura, and acute cluster headaches in adults | 6/27/2016 |
| Lutera 28 | Alesse | Larissia | Amneal Pharmaceuticals | oral contraception | 6/29/2016 |
