| Reference Listed Drug | NDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
|---|---|---|---|---|---|
| Ortho-Tri-Cyclen Lo | Janssen | Norgestimate / Ethinyl Estradiol | Mylan | used by women to prevent pregnancy | 1/5/2016 |
| Ortho-Tri-Cyclen Lo | Janssen | Norgestimate / Ethinyl Estradiol | Teva | used by women to prevent pregnancy | 1/5/2016 |
| Ortho-Tri-Cyclen Lo | Janssen | Norgestimate / Ethinyl Estradiol | Lupin | used by women to prevent pregnancy | 1/6/2016 |
| Felbatol | Meda | Felbamate | Mylan | monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children | 1/19/2016 |
| Gleevec | Novartis AG | Imatinib Mesylate | Sun Pharms | Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase; myelodysplastic/myeloproliferative diseases (MDS/MPD); aggressive systemic mastocytosis; (ASM); hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) | 2/1/2016 |
| Glumetza HCI ER | Santarus | Metformin Hydrochloride ER | Lupin | indicated as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus | 2/2/2016 |
| Pulmicort Respules | AstraZeneca | Budesonide Inhalation Suspension | Teva | indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age | 3/9/2016 |
| Campral | Merck | Acamprosate Calcium DR | Teva | used for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at the start of treatment | 3/22/2016 |
| Intermezzo | Purdue Pharma | Zolpidem Tartrate | Lupin | indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep | 3/22/2016 |
| Voltaren Gel | Novartis | Diclofenac Sodium Topical Gel 1% | Amneal | non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as knees and those of the hands | 3/24/2016 |
| Nasonex | Merck | Mometasone Furoate Monohydrate | Apotex | indicated for treatment of nasal congestion | 3/24/2016 |
| Ultram ER | Valeant | Tramadol Hydrochloride ER | Mylan | indicated for management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time | 3/28/2016 |
| Aricept | Eisai | Donepezil Hydrochloride | Lupin | indicated for treatment of dementia of the Alzheimer's type | 3/31/2016 |
