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 |