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Generic Launches

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 antiā€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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