Reference Listed Drug

NDA Holder

Generic Drug Name

ANDA
Applicant(s)

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