| Reference Listed Drug | NDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
|---|---|---|---|---|---|
| Tygacil | Pfizer | tigecycline | Apotex | used to treat infections caused by susceptible strains of the designated microorganisms in complicated skin and skin structure Infections, complicated intra-abdominal Infections and community-acquired bacterial pneumonia | 4/3/2019 |
| Abreva | Glaxo | docosanol | Teva | used to treat cold sores/fever blisters on the face or lips, shortens healing time and duration of symptoms | 4/3/2019 |
| Invanz | Merck | ertapenem | Apotex | used to treat adult patients and pediatric patients (3 months of age and older) with the moderate to severe infections caused by susceptible isolates of the designated microorganisms in complicated intra-abdominal infections, complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis, community acquired pneumonia, compicated urinary tract infections including pyelonephritis and acute pelvic infections including postpartum endomyometritis, septic abortion and post surgical gynecologic infections | 4/4/2019 |
| Proventil | Merck | albuterol | Endo's Par | used to treat shortness of breath associated with asthma and chronic obstructive pulmonary disease | 4/5/2019 |
| Xeloda | Roche | capecitabine | Armas | used to treat colon cancer, and breast or colorectal cancer that has spread to other parts of the body | 4/9/2019 |
| Gleevec | Roche | imatinib | Armas | used to treat certain types of leukemia (blood cancer), bone marrow disorders, and skin cancer. Imatinib is also used to treat certain tumors of the stomach and digestive system | 4/9/2019 |
| Androgel | AbbVie | testosterone | Teva | used as replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired), and hypogonadotropic hypogonadism (congenital or acquired) | 4/11/2019 |
| Vesicare | Astellas | solifenacin | Teva | used for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency | 4/22/2019 |
| Letairis | Gilead | ambrisentan | Cipla | used for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and delay clinical worsening | 4/30/2019 |
| Letairis | Gilead | ambrisentan | Teva | used for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and delay clinical worsening | 5/1/2019 |
| Androgel | AbbVie | testosterone | Dr. Reddy’s Labs. | used as replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired), and hypogonadotropic hypogonadism (congenital or acquired) | 5/6/2019 |
| Namenda XR | Allergan | memantine | Apotex | used for the treatment of moderate to severe dementia of the Alzheimer’s type | 5/10/2019 |
| Onfi | Lundbeck | clobazam | Lupin | used for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients 2 years of age or older | 5/10/2019 |
| Tarceva | OSI | erlotinib | Mylan | used for the treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen and also for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine | 5/10/2019 |
| Tarceva | OSI | erlotinib | Teva | used for the treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen and also for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine | 5/10/2019 |
| Delzicol | Allergan | mesalamine | Teva | used for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older, and for the maintenance of remission of ulcerative colitis in adults | 5/10/2019 |
| Cuprimine | Bausch & Lomb | penicillamine | Amerigen | used for the treatment of Wilson’s disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy | 5/13/2019 |
| Cubicin | Merck | daptomycin | Dr. Reddy’s Labs. | used for treating complicated skin infections | 5/15/2019 |
| Adderall IR | Shire | dextroamphetamine saccharate / amphetamine aspartate / dextroamphetamine sulfate / amphetamine sulfate | Lannett | used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy | 5/16/2019 |
| Cardizem CD | Bausch & Lomb | diltiazem | TWi | used for the treatment of hypertension and for the management of chronic stable angina and angina due to coronary artery spasm | 5/16/2019 |
| Vesicare | Astellas | solifenacin | Apotex | used for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency | 5/21/2019 |
| Pulmicort Respules | AstraZeneca | budesonide | Lupin | used for the maintenance treatment of asthma and as prophylactic therapy in children from 12 months to 8 years of age | 5/22/2019 |
| Ranexa | Gilead | ranolazine | Teva | used for the treatment of chronic angina | 5/28/2019 |
| Concerta | Johnson & Johnson | methylphenidate | Lannett | used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) | 5/29/2019 |
| Benadryl | Johnson & Johnson | diphenhydramine | Armas | used for the treatment of seasonal allergies, insect bites and stings, and rashes | 5/31/2019 |
| Faslodex | AstraZeneca | fulvestrant | Sandoz | used for treatment of estrogen receptor positive metastatic breast cancer (cancer that has spread) in postmenopausal women, with disease progression following antiestrogen therapy | 5/31/2019 |
| Tracleer | Actelion | bosentan | Hikma | used for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adults | 6/10/2019 |
| Albenza | Amneal | albendazole | Teva | used to treat certain infections caused by worms such as pork tapeworm and dog tapeworm | 6/14/2019 |
| K-Tab | AbbVie | potassium chloride | Adare Pharms | used to treat or prevent low amounts of potassium in the blood | 6/5/2019 |
| Aggrenox | Boehringer Ingelheim | aspirin / dipyridamole | Lannett | used to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis | 6/19/2019 |
| Tracleer | Actelion | bosentan | Teva | used for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adults | 6/20/2019 |
| Precedex | Hospira | dexmedetomidine | Fresenius Kabi | used for sedation of non-intubated patients prior to and/or during surgical and other procedures | 6/21/2019 |
| Canasa | Allergan | mesalamine | Amring Pharms | used for the treatment of active ulcerative proctitis | 6/25/2019 |
| Diclegis | Duchesnay | doxylamine succinate / pyridoxine HCl | Teva | used for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management | 6/25/2019 |
| Tobi | Mylan | tobramycin | Dr. Reddy’s Labs. | used for the management of cystic fibrosis patients with P. aeruginosa | 6/26/2019 |
| Vitamin K1 | -- | phytonadione | Dr. Reddy’s Labs. | used to treat and prevent low levels of certain substances (blood clotting factors) that your body naturally produces | 6/26/2019 |
| Canasa | Allergan | mesalamine | Rising | used for the treatment of mildly to moderately active ulcerative proctitis | 6/26/2019 |
| Lotemax | Bausch & Lomb | loteprednol etabonate | Akorn | used for the treatment of post-operative inflammation following ocular surgery and the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation | 6/28/2019 |
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