| Reference Listed Drug | NDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
|---|---|---|---|---|---|
| Lidex Ointment | County Line Pharmaceuticals | Fluocinonide Ointment | Lupin | indicated for the relief of the inflammatory and pruritic manifestations of Corticosteroid-Responsive Dermatoses | 3/28/2019 |
| Ritalin | Novartis | Methylphenidate HCl ER Tablets | ANI | indicated for the treatment of ADHD in children 6 years of age and older, adolescents, and adults up to the age of 65 | 3/27/2019 |
| E.E.S. | Abbott Labs | Erythromycin Ethylsuccinate for Oral Suspension | ANI | indicated in the treatment of infections caused by susceptible strains of selected diseases | 3/27/2019 |
| Cialis | Eli Lilly and Company | Tadalafil Tablets | Apotex | used to treat Erectile Dysfunction (Impotence) and symptoms of Benign Prostatic Hypertrophy (Enlarged Prostate) | 3/27/2019 |
| Cialis | Eli Lilly and Company | Tadalafil Tablets | Dr. Reddy's | used to treat Erectile Dysfunction (Impotence) and symptoms of Benign Prostatic Hypertrophy (Enlarged Prostate) | 3/27/2019 |
| Prozac | Eli Lilly and Company | Fluoxetine Tablets | Upsher-Smith | used to treat depression, panic attacks, obsessive compulsive disorder, a certain eating disorder (Bulimia), and a severe form of premenstrual syndrome (Premenstrual Dysphoric Disorder) | 3/27/2019 |
| Cialis | Eli Lilly and Company | Tadalafil Tablets | Zydus | used to treat Erectile Dysfunction (Impotence) and symptoms of Benign Prostatic Hypertrophy (Enlarged Prostate) | 3/27/2019 |
| Remodulin | United Therapeutics Corporation | Treprostinil Injection | Sandoz | indicated for Pulmonary Arterial Hypertension (PAH) | 3/25/2019 |
| Levophed | Hospira | Norepinephrine Bitartrate Injection | Hikma | indicated for blood pressure control in certain acute hypotensive states | 3/22/2019 |
| Synthroid | AbbVie | Levothyroxine Sodium Tablets | Lupin | indicated for Hypothyroidisn and Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) | 3/22/2019 |
| Exjade | Novartis | Deferasirox Tablets for Oral Suspension | Teva | indicated for the treatment of chronic iron overload due to blood transfusions inpatients two years of age and older | 3/22/2019 |
| Exelon Patch | Novartis | Rivastigmine Transdermal System | Amneal | used to treat mild to moderate dementia caused by Alzheimer's or Parkinson's disease | 3/12/2019 |
| Rythmol SR | GlaxoSmithKline | Propafenone HCl ER Capsules | Vitruvias and Sinotherapeutics | is used to help prevent certain types of serious (possibly fatal) irregular heartbeat (such as Paroxysmal Supraventricular is indicated for the treatment of sustained Ventricular Tachycardia that is deemed to be life-threatening | 3/8/2019 |
| Amrix | Teva | Cyclobenzaprine HCl ER Capsules | Teva | for use as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful masculoskeleal conditions | 3/6/2019 |
| Humalog | Eli Lilly and Company | Insulin Lispro Injection | Eli Lilly and Company (ImClone) | used to control high blood sugar in adults and children with diabetes mellitus | 3/4/2019 |
| Tekturna | Noden Pharma DAC | Aliskiren Hemifumarate Tablets | Prasco | indicated for the treatment of Hypertension in adults and children 6 years of age and older | 3/4/2019 |
| Amrix | Teva | Cyclobenzaprine HCl ER Capsules | Apotex | is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions | 3/1/2019 |
| Lovaza | GlaxoSmithKline | Omega-3 Acid Ethyl Esters Capsules | Camber Pharmaceuticals | used to lower levels of Triglycerides and may raise "good" Cholesterol | 3/1/2019 |
| Flector Patch | IBSA Institute Biochimique SA | Diclofenac Epolamine Topical Patch | Teva | used as a pain reliver indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions | 3/1/2019 |
| Amrix | Teva | Cyclobenzaprine HCl ER Capsules | Twi | indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions | 3/1/2019 |
| Rocephin | Hoffmann La Roche | Ceftriaxone for Injection | Apotex | used to treat conditions such as lower respiratory tract infections, skin and skin structure infections, urinary tract infections, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, and Meningitis | 2/28/2019 |
| Ranexa | Gilead Sciences | Ranolazine ER Tablets | Lupin | indicated for the treatment of chronic angina | 2/28/2019 |
| Ocuflox | Allergan | Ofloxacin Ophthalmic Solution | Apotex | used to treat bacterial infections of the eye, including Conjunctivitis (pink eye) and ulcers of the cornea | 2/27/2019 |
| Solodyn | Medicis Pharmaceutical | Minocycline HCl ER Tablets | Lupin | indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older | 2/26/2019 |
| Suboxone | Indivior | Buprenorphine HCl / Naloxone HCl | Mylan | for treatment of Opioid dependence | 2/22/2019 |
| Solodyn | Medicis Pharmaceutical | Minocycline HCl ER Tablets | Teva | indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older | 2/21/2019 |
| Acanya Gel | Dow Pharmaceutical Sciences | Clindamycin Phosphate / Benzoyl Peroxide Gel | Teva | indicated for the topical treatment of acne vulgaris in patients 12 years or older | 2/21/2019 |
| Suboxone | Indivior | Buprenorphine HCl / Naloxone HCl | Alvogen | for treatment of Opioid dependence | 2/20/2019 |
| Suboxone | Indivior | Buprenorphine HCl / Naloxone HCl | Dr. Reddy's | for treatment of Opioid dependence | 2/20/2019 |
| Zarontin | Pfizer | Ethosuximide Softgel Capsules | Strides Shasun | is an anti‐epileptic medication to control brief, sudden loss of consciousness and uncontrolled jerking movements in children and adults |
2/20/2019 |
| Suboxone | Indivior | Buprenorphine HCl / Naloxone HCl | Sandoz | for treatment of Opioid dependence | 2/19/2019 |
| Onfi | Lundbeck | Clobazam Oral Suspension | Lupin | indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older | 2/15/2019 |
| Zytiga | Janssen | Abiraterone Acetate Tablets | Hikma | indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) | 2/14/2019 |
| Detrol LA | Pharmacia & Upjohn | Tolterodine Tartrate ER Capsules | Camber Pharmaceuticals | used to treat overactive bladder | 2/13/2019 |
| Achromycin | Heritage Pharms | Tetracycline Capsules | Breckenridge | used to treat many different bacterial infections, such as Urinary Tract Infections (UTI), Acne, Gonorrhea, Chlamydia, and others | 2/12/2019 |
| Adcirca | Eli Lilly and Company | Tadalafil Tablets | Dr. Reddy's | indicated for the treatment of Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise ability | 2/12/2019 |
| Adcirca | Eli Lilly and Company | Tadalafil Tablets | Lupin | indicated for the treatment of Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise ability | 2/12/2019 |
| Advair Diskus | Glaxo | Fluticasone Propionate / Salmeterol Inhalation Powder | Mylan | is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma or ongoing lung disease (Chronic Obstructive Pulmonary Disease-COPD, which includes Chronic Bronchitis and Emphysema) | 2/12/2019 |
| Advair Diskus | Glaxo | Fluticasone Propionate / Salmeterol Inhalation Powder | Prasco | is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma or ongoing lung disease (Chronic Obstructive Pulmonary Disease-COPD, which includes Chronic Bronchitis and Emphysema) | 2/8/2019 |
| Adcirca | Eli Lilly and Company | Tadalafil Tablets | Cipla | indicated for the treatment of Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise ability | 2/7/2019 |
| Adcirca | Eli Lilly and Company | Tadalafil Tablets | Camber Pharmaceuticals | indicated for the treatment of Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise ability | 2/6/2019 |
| Sabril | Lundbeck | Vigabatrin Tablets | Teva | indicated as adjunctive therapy for adults and children (10 years of age or older) with refractory Complex Partial Seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss | 2/6/2019 |
| Norco | Warner Chilcott | Hydrocodone APAP Tablets | Camber Pharmaceuticals | used to relieve moderate to severe pain | 2/5/2019 |
| Anafranil | SpecGx | Clomipramine HCl Capsules | Lupin | treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD) | 2/5/2019 |
| Adcirca | Eli Lilly and Company | Tadalafil Tablets | Teva | indicated for the treatment of Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise ability | 2/5/2019 |
| Diprivan | Fresenius Kabi | Propofol Injectable Emulsion | Dr. Reddy's | used as initiation and maintenance of Monitored Anesthesia Care (MAC) sedation; combined sedation and regional anesthesia; induction of General Anesthesia Patients greater than or equal to 3 years of age; maintenance of General Anesthesia Patients greater than or equal to 2 months of age; Intensive Care Unit (ICU) sedation of intubated, mechanically ventilated patients | 1/24/2019 |
| Suprane | Baxter Healthcare | Desflurane, Liquid for Inhalation | Sandoz | is an inhalation agent indicated: for induction and/or maintenance of anesthesia in adults (1.1); for maintenance of anesthesia in pediatric patients following induction with agents other than Suprane and intubation | 1/24/2019 |
| Comtan | Novartis | Entacapone Tablets | Lannett | used in the treatment of Parkinson's Disease as an adjunct to Levodopa/Carbidopa Therapy | 1/22/2019 |
| Lovenox | Sanofi Aventis | Enoxaparin Sodium Injection | Apotex | is an anticoagulant (blood thinner) used to prevent blood clots that are sometimes called Deep Vein Thrombosis (DVT), which can lead to blood clots in the lungs | 1/16/2019 |
| Symjepi | Adamis Pharmaceuticals | Epinephrine for Injection | Sandoz | for the emergency treatment of allergic reactions (Type 1), including Anaphylaxis | 1/16/2019 |
| Trandate | County Line Pharmaceuticals | Labetalol HCL Tablets | TWi Pharmaceuticals | indicated for the treatment of Hypertension | 1/16/2019 |
| Albenza | Impax Labs | Albendazole Tablets | Camber Pharmaceuticals | used to treat infections of tapeworms or other parasites | 1/14/2019 |
| Zytiga | Janssen | Abiraterone Acetate | Amneal | is used along with prednisone to treat men with prostate cancer that has spread to other areas of the body | 1/9/2019 |
| Levitra | Baxter Healthcare | Vardenafil HCl Tablets | Teva | indicated for the treatment of Erectile Dysfunction | 1/8/2019 |
| Amgen | Sensipar | Cinacalcet HCl Tablets | Teva | indicated for secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis; also used for the treatment of Hypercalcemia in adult patients with Parathyroid Carcinoma and severe Hypercalcemia in adult patients with primary HPT who are unable to undergo Parathyroidectomy | 12/27/2018 |
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