| 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 |
