| Approval Date | Reference Listed Drug | Generic Drug Name | NDA Holder | ANDA Applicant |
|---|---|---|---|---|
| 07/01/2019 | Hygroton | chlorthalidone | Sanofi Aventis | Amneal |
| 07/01/2019 | Uloric | febuxostat | Takeda | Mylan |
| 07/01/2019 | Uloric | febuxostat | Takeda | Alembic |
| 07/01/2019 | Uloric | febuxostat | Takeda | Sun Pharm |
| 07/01/2019 | Haldol | haloperidol | Janssen | Fresenius Kabi USA |
| 07/01/2019 | Omidria | ketorolac tromethamine / phenylephrine HCl | Omeros | Lupin |
| 07/02/2019 | Hemabate | carboprost tromethamine | Pharmacia and Upjohn | Dr Reddys |
| 07/02/2019 | Ery-Tab | erythromycin | Arbor | Amneal |
| 07/02/2019 | Sporanox | itraconazole | Johnson & Johnson | Pii |
| 07/02/2019 | MetroGel-Vaginal Gel | metronidazole | Bausch | Perrigo |
| 07/02/2019 | Cytotec | misoprostol | Pfizer | Zydus |
| 07/02/2019 | Ultram | tramadol HCl | Johnson & Johnson | Polygen Pharms |
| 07/03/2019 | Syprine | trientine HCl | Aton | Dr Reddys |
| 07/05/2019 | Trilipix | fenofibric acid | Abbvie | TWi |
| 07/05/2019 | Fluoxetine HCl | fluoxetine HCl | Alvogen | G and W Labs |
| 07/05/2019 | Ranexa | ranolazine | Gilead | Glenmark Pharms |
| 07/08/2019 | Effexor XR | venlafaxine HCl | Pfizer | Annora Pharma |
| 07/09/2019 | Atelvia | risedronate sodium | Allergan | Sun Pharm |
| 07/10/2019 | Zytiga | abiraterone acetate | Johnson & Johnson | MSN Labs |
| 07/10/2019 | Onfi | clobazam | Lundbeck | Vistapharm |
| 07/10/2019 | Neoral | cyclosporine | Novartis | Apotex |
| 07/10/2019 | Lovaza | omega-3-acid ethyl esters | Glaxo | Sofgen Pharms |
| 07/12/2019 | Cubicin | daptomycin | Cubist | Accord Healthcare |
| 07/12/2019 | Edecrin | ethacrynic acid | Bausch | Agnitio |
| 07/12/2019 | Lymphazurin | isosulfan blue | Mylan | Somerset Theraps |
| 07/12/2019 | Technescan Mag3 | technetium tc 99m mertiatide kit | Curium | Pharmalucence |
| 07/15/2019 | Firazyr | icatibant acetate | Shire | Teva |
| 07/15/2019 | Concerta | methylphenidate HCl | Johnson & Johnson | Par |
| 07/16/2019 | Cosmegen | dactinomycin | Recordati | Hisun Pharm Hangzhou |
| 07/17/2019 | Adderall XR | dextroamphetamine saccharate / amphetamine aspartate monohydrate / dextroamphetamine sulfate / amphetamine sulfate | Shire | Nesher Pharms |
| 07/17/2019 | Cyklokapron | tranexamic acid | Pharmacia and Upjohn | Caplin |
| 07/17/2019 | Cyklokapron | tranexamic acid | Pharmacia and Upjohn | Apollo Pharms |
| 07/18/2019 | Trilipix | fenofibric acid | Abbvie | Graviti Pharms |
| 07/18/2019 | Benicar | olmesartan medoxomil | Daiichi Sankyo | Umedica Labs |
| 07/19/2019 | Focalin | dexmethylphenidate HCl | Novartis | Alkem |
| 07/19/2019 | Lyrica | pregabalin | Pfizer | Teva |
| 07/19/2019 | Lyrica | pregabalin | Pfizer | Teva |
| 07/19/2019 | Lyrica | pregabalin | Pfizer | Alembic Pharms |
| 07/19/2019 | Lyrica | pregabalin | Pfizer | Alkem |
| 07/19/2019 | Lyrica | pregabalin | Pfizer | Alkem |
| 07/19/2019 | Lyrica | pregabalin | Pfizer | Sciegen Pharms |
| 07/19/2019 | Lyrica | pregabalin | Pfizer | MSN Labs |
| 07/19/2019 | Lyrica | pregabalin | Pfizer | Dr Reddys |
| 07/19/2019 | Lyrica | pregabalin | Pfizer | Amneal |
| 07/19/2019 | Lyrica | pregabalin | Pfizer | Rising |
| 07/19/2019 | Lyrica | pregabalin | Pfizer | Cipla |
| 07/22/2019 | Fanapt | iloperidone | Vanda | Taro Pharm |
| 07/22/2019 | Morphine Sulfate | morphine sulfate | Hikma | Upsher Smith Labs |
| 07/22/2019 | Rozarem | ramelteon | Takeda | Zydus |
| 07/23/2019 | Faslodex | fulvestrant | Astra-Zeneca | Mylan |
| 07/23/2019 | Yaz | kyra | Bayer | Sun Pharm |
| 07/24/2019 | Mycostatin | nystatin | Delcor Asset Corp | Torrent |
| 07/25/2019 | Lotrimin | clotrimazole | Schering Plough | Tasman Pharma |
| 07/25/2019 | Trilipix | fenofibric acid | Abbvie | Aurobindo |
| 07/26/2019 | Truvada | emtricitabine / tenofovir disoproxil fumarate | Gilead | Laurus Labs |
| 07/26/2019 | Nicorette | nicotine polacrilex | Glaxo | Teva |
| 07/29/2019 | Zosyn | piperacillin / tazobactam | Astral | Astral |
| 07/30/2019 | Gablofen | baclofen | Piramal | Maia Pharms |
| 07/30/2019 | Solodyn ER | minocycline HCl | Bausch | Mylan Labs |
| 07/30/2019 | Norcuron | vecuronium bromide | Organon | Hikma |
| 07/31/2019 | Colcrys | colchicine | Takeda | Teva |
| 08/01/2019 | Hiprex | methenamine hippurate | US Pharma | Micro Labs |
| 08/01/2019 | Visken | pindolol | Novartis | Bayshore Pharms |
| 08/01/2019 | Tasmar | tolcapone | Bausch | Kinedexe |
| 08/02/2019 | Sporanox | itraconazole | Johnson & Johnson | Apotex |
| 08/02/2019 | Patanol | olopatadine HCl | Novartis | Gland Pharma |
| 08/02/2019 | Quelicin | succinylcholine chloride | Hospira | Dr Reddys |
| 08/05/2019 | Evekeo | amphetamine sulfate | Arbor | Granules Pharms |
| 08/05/2019 | Depakene | valproic acid | Abbvie | Novelgenix Theraps |
| 08/05/2019 | Navelbine | vinorelbine tartrate | Pierre Fabre Medicament | Ingenus Pharms |
| 08/06/2019 | Hygroton | chlorthalidone | Sanofi-Aventis | Unichem Labs |
| 08/07/2019 | Celebrex | celecoxib | Searle | Qingdao Baheal Pharm |
| 08/07/2019 | Lovaza | omega-3-acid ethyl esters | Glaxo | Bionpharma |
| 08/08/2019 | Aromasin | exemestane | Pharmacia and Upjohn | Mayne Pharma |
| 08/08/2019 | Makeena | hydroxyprogesterone caproate | Amag | Aspen |
| 08/08/2019 | Reclast | zoledronic acid | Novartis | Gland Pharma |
| 08/09/2019 | Trusopt | dorzolamide HCl | Merck | Alembic |
| 08/09/2019 | Tricor | fenofibrate | Abbvie | Alembic |
| 08/09/2019 | Makeena | hydroxyprogesterone caproate | Amag | Am Regent |
| 08/09/2019 | Keppra | levetiracetam | UCB | Micro Labs |
| 08/09/2019 | Ultram | tramadol HCl | J&J | Unichem Labs |
| 08/12/2019 | Halog | halcinonide | Sun | Mylan |
| 08/12/2019 | Combivir | lamivudine / zidovudine | Glaxo | Mylan |
| 08/13/2019 | Toviaz | fesoterodine fumarate | Pfizer | Dr Reddys |
| 08/13/2019 | Salagen | pilocarpine HCl | Eisai | Aurobindo |
| 08/13/2019 | Zemuron | rocuronium bromide | Organon | Camargo Pharm |
| 08/14/2019 | Brevibloc | esmolol hydrochloride | Baxter | Gland Pharma |
| 08/14/2019 | Carnitor | levocarnitine | Leadiant Biosciences | Novitium Pharma |
| 08/14/2019 | Carnitor SF | levocarnitine sugar free | Leadiant Biosciences | Novitium Pharma |
| 08/15/2019 | Westcort | hydrocortisone valerate | Sun | Lupin |
| 08/15/2019 | Percocet | oxycodone / acetaminophen | Vintage Pharma | Halo Pharm |
| 08/16/2019 | Cymbalta | duloxetine HCl | Eli Lilly | Yaopharma |
| 08/16/2019 | Fusilev | levoleucovorin calcium | Spectrum | Nanjing King-Friend |
| 08/16/2019 | Merrem | meropenem | Astra-Zeneca | HQ Specialty Pharma |
| 08/16/2019 | Torisel | temsirolimus | Pfizer | Gland Pharma |
| 08/19/2019 | Acanya | clindamycin phosphate / benzoyl peroxide | Bausch | Taro |
| 08/19/2019 | Acanya | clindamycin phosphate / benzoyl peroxide | Bausch | Tolmar |
| 08/19/2019 | Proamatine | midodrine HCl | Shire | Rubicon |
| 08/19/2019 | Protonix IV | pantoprazole sodium | Wyeth | Sun Pharm |
| 08/19/2019 | Ranexa | ranolazine | Gilead | Zydus |
| 08/19/2019 | Zioptan | tafluprost | Santen | Micro Labs |
| 08/19/2019 | Detrol LA | tolterodine tartrate | Pharmacia and Upjohn | Inventia Healthcare |
| 08/19/2019 | Dyrenium | triamterene | Concordia | Agnitio |
| 08/20/2019 | Kuvan Powder | sapropterin dihydrochloride | Biomarin | Par |
| 08/20/2019 | Kuvan Tablet | sapropterin dihydrochloride | Biomarin | Par |
| 08/21/2019 | Solodyn ER | minocycline HCl | Bausch | Aurobindo |
| 08/21/2019 | Solodyn ER | minocycline HCl | Bausch | Mylan |
| 08/21/2019 | Noxafil | posaconazole | Merck | Sinotherapeutics |
| 08/22/2019 | Cubicin | daptomycin | Cubist | Jiangsu Hengrui Med |
| 08/22/2019 | Faslodex | fulvestrant | Astra-Zeneca | Sagent |
| 08/22/2019 | Faslodex | fulvestrant | Astra-Zeneca | Glenmark |
| 08/22/2019 | Fusilev | levoleucovorin calcium | Spectrum | Nanjing King-Friend |
| 08/22/2019 | Methadose | methadone HCl | SPECGX | Pharm Assoc |
| 08/22/2019 | Aleve PM | naproxen sodium / diphenhydramine HCl | Bayer | Apotex |
| 08/23/2019 | Amicar | aminocaproic acid | Clover | Amneal |
| 08/23/2019 | Finacea | azelaic acid | Leo | Taro |
| 08/23/2019 | Astepro | azelastine HCl | Mylan | Hi Tech (Akorn) |
| 08/26/2019 | Orfadin | nitisinone | Sobi | Novitium Pharma |
| 08/27/2019 | Edecrin | ethacrynic acid | Bausch | Sciegen Pharms |
| 08/27/2019 | Vesicare | solifenacin succinate | Astellas | Unichem Labs |
| 08/28/2019 | Dacogen | decitabine | Otsuka | MSN Labs |
| 08/29/2019 | Elidel | pimecrolimus | Bausch | Glenmark |
| 08/29/2019 | Effexor XR | venlafaxine HCl | Pfizer | Cadila Pharms |
| 08/30/2019 | Relafen | nabumetone | SKB | Nexgen Pharma |
| 08/30/2019 | Aleve | naproxen sodium | Bayer | Yichang Humanwell |
| 08/30/2019 | Folxin OTIC | ofloxacin | Daiichi Sankyo | Amneal |
| 08/30/2019 | Zantac 150 | ranitidine HCl | Sanofi Aventis | Unique Pharm Labs |
| 08/30/2019 | Zantac 75 | ranitidine HCl | Sanofi Aventis | Unique Pharm Labs |
| 09/03/2019 | Xalatan | latanoprost | Pharmacia and Upjohn | Aurobindo |
| 09/03/2019 | Concerta | methylphenidate HCl | Johnson & Johnson | Ascent Pharms |
| 09/04/2019 | Latuda | lurasidone HCl | Sunovion | Emcure Pharms |
| 09/05/2019 | Wellbutrin XL | bupropion HCl | Valeant | Zhejiang Jutai Pharma |
| 09/05/2019 | Emend I.V. | fosaprepitant dimeglumine | Merck | Mylan |
| 09/05/2019 | Emend I.V. | fosaprepitant dimeglumine | Merck | Apotex |
| 09/05/2019 | Emend I.V. | fosaprepitant dimeglumine | Merck | MSN Labs |
| 09/05/2019 | Emend I.V. | fosaprepitant dimeglumine | Merck | Lupin |
| 09/05/2019 | Emend I.V. | fosaprepitant dimeglumine | Merck | Sungen Pharma |
| 09/05/2019 | Emend I.V. | fosaprepitant dimeglumine | Merck | Baxter Healthcare |
| 09/05/2019 | Emend I.V. | fosaprepitant dimeglumine | Merck | Be Pharms |
| 09/06/2019 | Zovirax | acyclovir | Bausch Health | Apotex |
| 09/06/2019 | Proventil | albuterol sulfate | Schering | Quagen |
| 09/06/2019 | Onfi | clobazam | Lundbeck | Alkem |
| 09/06/2019 | Colcrys | colchicine | Takeda | Dr Reddys |
| 09/06/2019 | Edecrin | ethacrynic acid | Bausch | Lupin |
| 09/06/2019 | Tricor | fenofibrate | Abbvie | Appco Pharma |
| 09/06/2019 | Nicorette | nicotine polacrilex | Glaxo | P and L Dev |
| 09/09/2019 | Kyprolis | carfilzomib | Onyx | Dr Reddys |
| 09/09/2019 | Acanya | clindamycin phosphate / benzoyl peroxide | Bausch | Perrigo |
| 09/09/2019 | Olux-E foam | clobetasol propionate | Mylan | Glenmark |
| 09/10/2019 | Tylenol w/ Codeine | acetaminophen / codeine phosphate | Janssen | Elite Labs |
| 09/11/2019 | Lioresal | baclofen | Saol Therapeutics | Maia Pharms |
| 09/12/2019 | Parafon Forte | chlorzoxazone | Janssen | Novitium Pharma |
| 09/13/2019 | Sinequan | doxepin HCl | Pfizer | Ajanta |
| 09/13/2019 | Soolantra | ivermectin | Galderma | Teva |
| 09/13/2019 | Alkeran | melphalan hydrochloride | Apotex | Noratech Pharma |
| 09/13/2019 | Corgard | nadolol | US Worldmeds | Vgyaan Pharma |
| 09/16/2019 | Lotronex | alosetron HCl | Sebela | Eywa Pharma |
| 09/16/2019 | Colcrys | colchicine | Takeda | Mylan |
| 09/16/2019 | Dacogen | decitabine | Otsuka | Ingenus Pharms |
| 09/16/2019 | Syprine | trientine HCl | Aton | Kadmon Pharms |
| 09/17/2019 | Benicar | olmesartan medoxomil | Daiichi Sankyo | Micro Labs |
| 09/17/2019 | Benicar HCT | olmesartan medoxomil / hydrochlorothiazide | Daiichi Sankyo | Umedica Labs |
| 09/20/2019 | Lyrica | pregabalin | Pfizer | Mylan |
| 09/20/2019 | Zomig-ZMT | zolmitriptan | Astra-Zeneca | Mylan |
| 09/23/2019 | Invega | paliperidone | Janssen | Amneal |
| 09/23/2019 | Androgel 1.62% | testosterone | Unimed | Twi |
| 09/24/2019 | Clobex | clobetasol propionate | Galderma | Zydus |
| 09/24/2019 | Remodulin | treprostinil | United Therapeutics | Par |
| 09/25/2019 | Baraclude | entecavir | Bristol Myers Squibb | Brightgene Bio-Medical Tech |
| 09/25/2019 | Syprine | trientine HCl | Aton | Par |
| 09/26/2019 | Hectorol | doxercalciferol | Genzyme | Gland Pharma |
| 09/26/2019 | Patanol | olopatadine HCl | Novartis | FDC |
| 09/26/2019 | Prilosec | omeprazole | Astra-Zeneca | Hetero Labs |
| 09/26/2019 | Vesicare | solifenacin succinate | Astellas | Strides Pharma |
| 09/26/2019 | Remodulin | treprostinil | United Therapeutics | Teva |
| 09/27/2019 | Zytiga | abiraterone acetate | Johnson & Johnson | Qilu Pharm |
| 09/27/2019 | Tikosyn | dofetilide | Pfizer | Wilshire Pharms |
| 09/30/2019 | Dilantin | extended phenytoin sodium | Parke-Davis | Lupin |
| 09/30/2019 | Robinul | glycopyrrolate | Hikma | Gland Pharma |
| 09/30/2019 | Potassium Chloride | potassium chloride | Merck | Yichang Humanwell |
| 09/30/2019 | Lyrica | pregabalin | Pfizer | Hainan Shuangcheng Pharma |
| 09/30/2019 | Lyrica | pregabalin | Pfizer | Alkem |
| 09/30/2019 | Viibryd | vilazodone HCl | Allergan | Teva |
