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 |