|
Reference Listed Drug |
NDA Holder |
Generic Drug Name |
ANDA |
Indication |
Launch Date |
|
Zemplar |
AbbVie |
Paricalcitol Capsules |
Teva |
Vitamin D preventions of secondary hyperparathyroidism in patients with Stage 3 of Stage 4 chronic kidney disease and in Stage 5 patients on dialysis |
10/1/2013 |
|
Zymaxid |
Allergan |
Gatifloxacin Opthalmic Solution, 0.5% |
Lupin Pharms |
treatment of bacterial conjunctivitis |
10/3/2013 |
|
Kapvay |
Concordia |
Clonidine Hydrochloride 0.1 mg Extended-release Tablets |
Par |
treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications |
10/7/2013 |
|
Reclast |
Novartis |
Zoledronic Acid Injection 5 mg in a Premix IV Bag |
Sagent Pharms |
treatment of Paget's Disease of bone in men and women |
10/11/2013 |
|
Paraplatin |
Corden Pharma |
Carboplatin Injection |
Sagent |
antineoplastic agent |
11/4/2013 |
|
Keppra |
UCB |
Levetiracetam Injection, in a preservative-free glass |
Sagent Pharms |
partial onset seizures, myoclonic seizures in those with juvenile myoclonic epilepsy, or primary generalized tonic-clonic seizures in those of idiopathic generalized epilepsy |
11/6/2013 |
|
Aciphex |
Eisai |
Rabeprazole Sodium Delayed-release Tablets, 20mg |
Lupin Pharms |
short-term treatment in healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease and for short-term treatment in the healing and symptomatic relief of duodenal ulcers |
11/11/2013 |
|
Aciphex |
Eisai |
Rabeprazole Sodium Delayed-release Tablets, 20mg |
Mylan |
short-term treatment in healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease and for short-term treatment in the healing and symptomatic relief of duodenal ulcers |
11/11/2013 |
|
Doxil |
Janssen Pharms |
Doxorubicin Hydrochloride Injection |
Sagent Pharms |
antineoplastic agent |
11/11/2013 |
|
Focalin XR |
Novartis |
Dexmethylphenidate Hydrochloride Extended-release Capsules, 30 mg |
Mylan |
treatment of attention deficit hyperactivity disorder (ADHD) in patients age 6 years and older |
11/18/2013 |
|
Diprivan |
Fresenius Kabi USA |
Propofol Injection Emulsion |
Sagent Pharms |
reduces anxiety and tension, promotes relaxation and sleep or loss of consciousness |
11/18/2013 |
|
Focalin XR |
Novartis |
Dexmethylphenidate Hydrochloride Extended-release Capsules, 15 mg and 30 mg |
Par |
treatment of attention deficit hyperactivity disorder (ADHD) in patients age 6 years and older |
11/20/2013 |
|
Solaraze Gel |
PharmaDerm |
Diclofenac 3% gel |
Impax |
topical treatment of actinic keratosis (AK) |
11/21/2013 |
|
Solaraze Gel |
PharmaDerm |
Diclofenac 3% gel |
Sandoz |
treatment of actinic keratosis (AK) (Topical) |
11/21/2013 |
|
Dostinex |
Pharmacia and Upjohn |
Cabergoline Tablets USP, 0.5 mg |
Mylan |
hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas |
12/5/2013 |
|
Trilipix |
AbbVie |
Fenofibric Acid Delayed-release Capsules |
Lupin Pharms |
co-administration therapy with statins for the treatment of mixed dyslipidemia, severe hypertriglyceridemia and primary hypercholesterolemia or mixed dyslipidemia |
12/6/2013 |
|
Locoid Lipcream |
Precision Dermatology |
Hydrocortisone Butyrate Cream USP, 0.1% |
Glenmark Generics |
relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults and the treatment for mild to moderate atopic dermatitis in patients 3 months to 18 years of age |
12/9/2013 |
|
Cymbalta |
Lilly |
Duloxetine Hydrochloride Delayed-release (HCI DR) Capsules |
Lupin Pharms |
treatment of major depressive disorder (MDD); generalized anxiety disorder (GAD) and management of neuropathic pain (NPNP) associated with diabetic peripheral neuropathic pain (DPNP) associated with diabetic peripheral neuropathy |
12/12/2013 |
|
Nexium |
AstraZeneca |
Esomeprazole Strontium Delayed-release Capsules |
Amneal Pharms |
short-term treatment of gastroesophageal reflux disease |
12/17/2013 |
|
Trizivir |
ViiV Healthcare |
Abacavir Sulfate / Lamivudine / Zidovudine Tablets, 300 mg (base)/150 mg/300 mg |
Lupin Pharms |
treatment for HIV-1 infection |
12/18/2013 |
|
Sandostatin |
Novartis |
Octreotide Acetate Injection |
Sagent Pharms |
treatment of severe waterydiarrheaand sudden reddening of the face and neck caused by certain types of tumors (e.g.,carcinoid tumors, vasoactive intestinal peptide tumors) that are found usually in the intestines and pancreas |
12/18/2013 |
