ANDA Approvals

Fall 2018

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant
7/2/2018	Emtriva	Emtricitabine	Gilead	Cipla
7/2/2018	Cancidas	Caspofungin Acetate	Merck	Xellia Pharms
7/2/2018	Rythmol SR	Propafenone HCl	GlaxoSmithKline	Wilshire Pharms
7/2/2018	Vidaza	Azacitidine	Celgene	Accord Healthcare
7/2/2018	Singulair	Montelukast Sodium	Merck Sharp Dohme	Unichem Labs
7/2/2018	Xeloda	Capecitabine	Hoffmann La Roche	MSN Labs
7/2/2018	Nicorette	Nicotine Polacrilex	GlaxoSmithKline	Watson
7/2/2018	Docetaxel	Docetaxel	Hospira	Mylan
7/2/2018	Bentyl	Dicyclomine HCl	Allergan	APC Pharms
7/3/2018	Plan B One-Step	Levonorgestrel	FDN Consumer	Haupt Pharma
7/3/2018	Uceris	Budesonide	Valeant	Actavis Labs FL
7/3/2018	Zyprexa Zydis	Olanzapine	Eli Lilly	HEC Pharm
7/3/2018	Haldol	Haloperidol Decanoate	Janssen Pharms	Somerset Theraps
7/5/2018	Temodar	Temozolomide	Merck Sharp Dohme	Apotex
7/5/2018	Zithromax	Azithromycin	Pfizer	Aurobindo
7/5/2018	Zithromax	Azithromycin	Pfizer	Aurobindo
7/5/2018	Vazculep	Phenylephrine HCl	West Ward Pharm / Avadel Legacy	Amneal
7/6/2018	Hepsera	Adefovir Dipivoxil	Gilead	Apotex
7/6/2018	Adrenalin	Epinephrine	Par Sterile Products	Luitpold
7/6/2018	Plaquenil	Hydroxychloroquine Sulfate	Concordia Pharms	Lupin
7/6/2018	Docetaxel	Docetaxel	Hospira	Mylan Labs
7/9/2018	Macrodantin	Nitrofurantoin	Alvogen	Novel Labs
7/9/2018	Tobi	Tobramycin	Novartis	Dr Reddys
7/9/2018	Xanax	Alprazolam	Pharmacia and Upjohn	Centaur Pharms PVT
7/10/2018	Bloxiverz	Neostigmine Methylsulfate	Avadel Legacy	Dr Reddys
7/11/2018	Namenda	Memantine HCl	Allergan	Apotex
7/11/2018	Zomig	Zolmitriptan	IPR	Zydus
7/11/2018	Ampyra	Dalfampridine	Acorda	Accord Healthcare
7/11/2018	D.H.E. 45	Dihydroergotamine Mesylate	Valeant	Sagent
7/11/2018	Mucinex	Guaifenesin	Reckitt Benckiser	Amneal
7/12/2018	Cancidas	Caspofungin Acetate	Merck	Cipla
7/13/2018	Oxytocin	Oxytocin	Fresenius Kabi USA & West-Ward Pharms / Par Sterile Products	Sagent
7/13/2018	Busulfex	Busulfan	Otsuka Pharm	Mylan
7/13/2018	Gleevec	Imatinib Mesylate	Novartis	West-Ward Pharms
7/13/2018	Elocon	Mometasone Furoate	Merck Sharp Dohme	Torrent
7/16/2018	Angiomax	Bivalirudin	The Medicines Co	Sagent
7/16/2018	Welchol	Colesevelam Hydrochloride	Daiichi Sankyo	Glenmark
7/16/2018	Glucotorol XL	Glipizide	Pfizer	Zydus
7/16/2018	Infumorph / Morphine Sulfate	Mitigo	West-Ward Pharms / Hospira	Piramal Critical
7/16/2018	Cleocin T	Clindamycin Phosphate	Pharmacia and Upjohn	Zydus
7/16/2018	Vfend	Voriconazole	PF Prism	Zydus
7/16/2018	Mucinex	Guaifenesin (OTC)	Reckitt Benckiser	OHM Labs
7/16/2018	Dextrose 10% in Plastic Container	Dextrose 10% in Plastic Container	B Braun / Baxter Healthcare / ICU Medical	Fresenius Kabi USA
7/16/2018	Minastrin 24 FE	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	Apil	Chemo Research SL
7/17/2018	Zyprexa	Olanzapine	Lilly	Zydus
7/17/2018	Feldene	Piroxicam	Pfizer	Zydus
7/17/2018	Saphris	Asenapine Maleate	Forest Labs	SigmaPharm Labs
7/17/2018	Lidex	Fluocinonide	County Line Pharms	Zydus
7/18/2018	Aldactone	Spironolactone	GD Searle	Zydus
7/19/2018	Zithromax	Azithromycin	Pfizer	Amneal
7/19/2018	Potassium Chloride	Potassium Chloride	Genus LifeSciences	Amneal
7/19/2018	Vazculep	Phenylephrine HCl	Avadel Legacy	Amneal
7/20/2018	Treximet	Sumatriptan / Naproxen Sodium	Pernix	Sun Pharma
7/20/2018	Integrilin	Eptifibatide	Schering	Mylan
7/20/2018	Acetadote	Acethylcysteine	Cumberland Pharms	Zydus
7/20/2018	Gemcitabine HCl	Gemcitabine HCl	Hospira	Sagent
7/20/2018	Cetirizine HCl	Cetirizine HCl	Bionpharma	Aurobindo
7/20/2018	Mestinon	Pyridostigmine Bromide	Valeant	Invatech Pharma
7/23/2018	Sodium Chloride 0.45% in Plastic Container	Sodium Chloride 0.45% in Plastic Container	B Braun / ICU Medical	Fresenius Kabi USA
7/23/2018	Corgard	Nadolol	US WorldMeds	Beximco Pharms
7/24/2018	Edecrin	Ethacrynic Acid	Aton	Alvogen
7/24/2018	Amrix	Cyclobenzaprine HCl	Teva	Apotex
7/24/2018	Cosopt / Cosopt PF	Dorzolamide HCl / Timolol Maleate	Oak Pharms	Aurobindo
7/25/2018	Indium in 111 Oxyquinoline	Indium in 111 Oxyquinoline	GE Healthcare	Nordion
7/25/2018	Intuniv	Guanfacine HCl	Shire	Apotex
7/25/2018	Targretin	Bexarotene	Valeant	Upsher-Smith Labs
7/27/2018	Azilect	Rasagiline Mesylate	Teva	Sandoz
7/27/2018	Aricept ODT	Donepezil HCl	Eisai	Hisun Pharm Hangzhou
7/27/2018	Angiomax	Bivalirudin	The Medicines Co	Aurobindo
7/27/2018	Aubagio	Teriflunomide	Sanofi Aventis	Watson
7/27/2018	Solaraze	Diclofenac Sodium	Fougera Pharms	Gage Development
7/30/2018	Torisel	Temsirolimus	PF Prism	Accord Healthcare
7/30/2018	Ampyra	Dalfampridine	Acorda	Alkem Labs
7/31/2018	Busulfex	Busulfan	Otsuka	Hospira
7/31/2018	Viread	Tenofovir Disoproxil Fumarate	Gilead Sciences	Apotex
7/31/2018	Singulair	Montelukast Sodium	Merck	Torrent
7/31/2018	Zithromax	Azithromycin	Pfizer	Zydus
8/15/2018	Minivelle / Climara	Estradiol	Noven / Bayer	Mylan
8/16/2018	EpiPen	Epinephrine (Autoinjector)	Mylan	Teva
8/17/2018	Taxol	Paclitaxel	HQ Spclt Pharma	Accord Healthcare
8/17/2018	Motrin	Ibuprofen	J and J Consumer	Guardian Drug
8/17/2018	Locoid	Hydrocortisone Butyrate	Precision Dermat	Lupin
8/20/2018	Zantac 150	Ranitidine HCl	Sanofi	Granules India
8/21/2018	Motrin IB	Ibuprofen	J and J Consumer	Aiping Pharm
8/21/2018	Precedex	Dexmedetomidine HCl	Hospira	Baxter
8/21/2018	Aggrenox	Aspirin / Dipyridamole	Boehringer Ingelheim	Sun Pharma
8/21/2018	Fluocinonide	Fluocinonide	Taro	Amneal
8/10/2018	Zosyn	Piperacillin / Tazobactam	Wyeth	Qilu Tianhe
8/13/2018	Gleevec	Imatinib Mesylate	Novartis	Dr Reddys Labs
8/13/2018	Allegra	Fexofenadine HCl	Sanofi Aventis	Unique Pharm Labs
8/22/2018	Truvada	Emtricitabine / Tenofovir Disoproxil Fumarate	Gilead	Amneal
8/22/2018	Bloxiverz	Neostigmine Methylsulfate	Avadel Legacy	Renaissance SSA
8/24/2018	Neurontin	Gabapentin	Pfizer	Lupin
8/24/2018	Sporanox	Itraconazole	Janssen	Torrent
8/24/2018	Docetaxel	Docetaxel	Hospira	Cipla
8/27/2018	Glucophage	Metformin HCl	Bristol-Myers Squibb	Laurus Labs
8/28/2018	Lopid	Gemfibrozil	Pfizer	Zydus
8/28/2018	Tricor	Fenofibrate	AbbVie	Prinston
8/29/2018	Combivir	Lamivudine / Zidovudine	ViiV Healthcare	MacLeods
8/29/2018	Potassium Chloride	Potassium Chloride	Genus LifeSciences	Novel Labs
8/30/2018	Cardizem CD	Diltiazem HCl	Valeant	TWi Pharms
8/30/2018	Sustiva	Efavirenz	Bristol-Myers Squibb	Aurobindo
8/30/2018	Azor	Amlodipine / Olmesartan Medoxomil	Daiichi Sankyo	Accord Healthcare
8/31/2018	Lomotil	Diphenoxylate HCl / Atropine Sulfate	GD Searle	Upsher-Smith Labs
8/31/2018	Klor-Con	Potassium Chloride	Upsher-Smith Labs	Strides
9/4/2018	Treximet	Sumatriptan / Naproxen Sodium	Pernix	Mylan
9/4/2018	Atripla	Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate	Gilead Sciences	Aurobindo
9/4/2018	Brilinta	Ticagrelor	AstraZeneca	Watson
9/4/2018	Aubagio	Teriflunomide	Sanofi Aventis	Teva
9/4/2018	Targretin	Bexarotene	Valeant	Amneal
9/5/2018	Imodium Multi-Symptom Relief	Loperamide HCl / Simethicone	J and J Consumer	Perrigo
9/7/2018	Combivir	Lamivudine / Zidovudine	ViiV Healthcare	Cipla
9/7/2018	Sandostatin	Octreotide Acetate	Novartis	USV North America
9/10/2018	Glucophage XR	Metformin HCl	Bristol-Myers Squibb	Prinston
9/10/2018	Magnesium Sulfate In Dextrose 5% Plastic Container	Magnesium Sulfate In Dextrose 5% Plastric Container	Hospira	Mylan
9/10/2018	Yasmin	Drospirenone / Ethinyl Estradiol	Bayer	Cyndea Pharma
9/11/2018	Atelvia	Risedronate Sodium	Apil	Zydus
9/11/2018	Mepron	Atovaquone	GlaxoSmithKline	Lupin
9/11/2018	BICNU	Carmustine	Emcure Pharms	Navinta
9/14/2018	Inspra	Eplerenone	GD Searle	Breckenridge
9/14/2018	Magnesium Sulfate in Plastic Container	Magnesium Sulfate in Plastic Container	Hospira	Mylan
9/14/2018	Vagifem	Estradiol	Novo Nordisk	Glenmark
9/14/2018	Clolar	Clofarabine	Genzyme	Ingenus Pharms
9/17/2018	Norvir	Ritonavir	AbbVie	Hetero Labs
9/17/2018	Norvir	Ritonavir	AbbVie	Aurobindo
9/17/2018	Norvir	Ritonavir	AbbVie	Amneal
9/18/2018	Plan B One-Step	Levonorgestrel	FDN Consumer	Apotex
9/18/2018	Achromycin V	Tetracycline HCl	Heritage Pharma	Amneal
9/19/2018	Aloxi	Palonosetron HCl	Helsinn	Sagent
9/19/2018	Aloxi	Palonosetron HCl	Helsinn	Qilu Pharm
9/19/2018	Aloxi	Palonosetron HCl	Helsinn	Sagent
9/19/2018	Abilify	Aripiprazole	Otsuka	Mylan
9/19/2018	Aloxi	Palonosetron HCl	Helsinn	Cipla
9/19/2018	Aloxi	Palonosetron HCl	Helsinn	Mylan
9/19/2018	Aloxi	Palonosetron HCl	Helsinn	Fresenius Kabi USA
9/19/2018	Aloxi	Palonosetron HCl	Helsinn	Fresenius Kabi USA
9/19/2018	Aloxi	Palonosetron HCl	Helsinn	Hospira
9/19/2018	Focalin	Dexmethylphenidate HCl	Novartis	Cediprof
9/19/2018	Aloxi	Palonosetron HCl	Helsinn	Virtus Pharm
9/21/2018	Sustiva	Efavirenz	Bristol-Myers Squibb	Aurobindo Pharma
9/21/2018	Albenza	Albendazole	Impax Labs	Cipla
9/24/2018	Zithromax	Azithromycin	Pfizer	CSPC Ouyi Pharm
9/24/2018	Reyataz	Atazanavir Sulfate	Bristol-Myers Squibb	Mylan
9/24/2018	Skelaxin	Metaxalone	King Pharms	Appco Pharma
9/24/2018	Zyprexa	Olanzapine	Eli Lilly	Jiangsu Hansoh Pharm
9/24/2018	Vibramycin	Doxycycline Hyclate	Pfizer	Ajanta Pharma
9/24/2018	Glucophage XR	Metformin HCl	Bristol-Myers Squibb	Yichang Humanwell
9/26/2018	Children's Motrin	Ibuprofen	J and J Consumer	Guardian Drug
9/28/2018	Lovenox (Preservative Free)	Enoxaparin Sodium	Sanofi Aventis	Apotex
9/28/2018	Solodyn	Minocycline HCl	Medicis	Aurobindo Pharma
9/28/2018	Avelox	Moxifloxacin HCl	Bayer	Sunshine Lake
9/28/2018	Lidex	Fluocinonide	Cnty Line Pharms	Teligent Pharma
9/28/2018	Seroquel XR	Quetiapine Fumarate	AstraZeneca	Alignscience Pharma
9/28/2018	Aubagio	Teriflunomide	Sanofi Aventis	Amneal