This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA.
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Approval Date |
Reference Listed Drug |
Generic Drug Name |
NDA Holder |
ANDA Applicant |
01/04/2021 |
Cyanocobalamin |
cyanocobalamin |
American Regent |
Sandoz |
01/05/2021 |
Xylocaine |
lidocaine |
AstraZeneca |
Dr Reddys Labs |
01/05/2021 |
Bactrim |
sulfamethoxazole / trimethoprim |
Sun |
Lupin |
01/06/2021 |
Tirosint |
levothyroxine sodium |
IBSA |
Teva |
01/07/2021 |
Biorphen |
phenylephrine HCl |
Hikma |
Aurobindo |
01/07/2021 |
Pentam |
pentamidine isethionate |
Fresenius Kabi |
Emcure Pharms |
01/07/2021 |
Prolixin |
fluphenazine HCl |
BMS |
Cerovene |
01/07/2021 |
Claritin |
loratadine |
Bayer |
Unique Pharm |
01/11/2021 |
Axiron |
testosterone |
Eli Lilly |
Fempharm |
01/11/2021 |
Zovirax |
acyclovir |
Mylan |
Vistapharm |
01/12/2021 |
Emend |
fosaprepitant dimeglumine |
Merck |
Aurobindo |
01/12/2021 |
Celebrex |
celecoxib |
Pfizer |
Unichem |
01/13/2021 |
Truvada |
emtricitabine / tenofovir disoproxil fumarate |
Gilead |
Strides |
01/13/2021 |
Rayven (NuvaRing) |
ethinyl estradiol / etonogestrel |
Merck |
Teva |
01/13/2021 |
Adderall 30 |
dextroamp saccharate / amp aspartate / dextroamp sulfate / amp sulfate |
Teva |
Rhodes Pharms |
01/13/2021 |
Lopid |
gemfibrozil |
Pfizer |
Ascent Pharms |
01/14/2021 |
Taxotere |
docetaxel |
Sanofi Aventis |
Hikma |
01/14/2021 |
Renvela |
sevelamer carbonate |
Genzyme |
Lupin |
01/14/2021 |
Targretin |
bexarotene |
Bausch & Lomb |
Teva |
01/14/2021 |
Glumetza ER |
metformin HCl |
Bausch & Lomb |
Granules |
01/15/2021 |
Feraheme |
ferumoxytol |
AMAG |
Sandoz |
01/15/2021 |
Veletri |
epoprostenol sodium |
Actelion |
Sun |
01/15/2021 |
Lioresal |
baclofen |
Saol Therapies |
Maia Pharms |
01/15/2021 |
Methergine |
methylergonovine maleate |
Edison Therapeutics |
Rising |
01/15/2021 |
CellCept |
mycophenolate mofetil HCl |
Roche |
Nanjing King-Friend (Meitheal) |
01/19/2021 |
Gilenya |
fingolimod HCl |
Novartis |
Mylan |
01/19/2021 |
Lamictal ODT |
lamotrigine |
Glaxo |
Ajanta Pharma |
01/21/2021 |
Monodox |
doxycycline |
Chartwell |
Mylan |
01/21/2021 |
Tamiflu |
oseltamivir phosphate |
Roche |
Mylan |
01/21/2021 |
Venlafaxine Hydrochloride |
venlafaxine hydrochloride |
Osmotica |
Dexcel Pharma |
01/21/2021 |
Argatroban |
argatroban |
Eagle |
Caplin |
01/21/2021 |
ProAmtine |
midodrine HCl |
Takeda |
Alembic Pharms |
01/22/2021 |
Actos |
pioglitazone HCl |
Takeda |
Shuangcheng |
01/22/2021 |
Actigall |
ursodiol |
AbbVie |
Strides |
01/22/2021 |
Tobi |
tobramycin |
Mylan |
Aurobindo |
01/22/2021 |
Thorazine |
chlorpromazine HCl |
Glaxo |
Lannett |
01/22/2021 |
Albenza |
albendazole |
Amneal |
MSN |
01/22/2021 |
Evekeo |
amphetamine sulfate |
Arbor |
SpecGx |
01/22/2021 |
Levophed |
norepinephrine bitartrate |
Hospira |
Breckenridge |
01/22/2021 |
Cytomel |
liothyronine sodium |
King |
Zydus |
01/25/2021 |
Trisenox |
arsenic trioxide |
Teva |
Amneal |
01/25/2021 |
Mexitil |
mexiletine HCl |
Boehringer-Ingelheim |
Riconpharma |
01/26/2021 |
Zyclara 3.75% |
imiquimod |
Galderma |
Taro |
01/26/2021 |
Albenza |
albendazole |
Amneal |
Dr Reddys Labs |
01/26/2021 |
Sabril |
vigabatrin |
Lundbeck |
Annora Pharma |
01/26/2021 |
Amicar |
aminocaproic acid |
Akorn |
Leading Pharma |
01/26/2021 |
Zonegran |
zonisamide |
Sunovion |
Unichem |
01/27/2021 |
Lomotil |
diphenoxylate HCl / atropine sulfate |
Pfizer |
Winder Labs |
01/27/2021 |
Evekeo |
amphetamine sulfate |
Arbor |
Glenmark |
01/27/2021 |
Evekeo |
amphetamine sulfate |
Arbor |
Sun |
01/27/2021 |
Furosemide |
furosemide |
American Regent |
Athenex |
01/28/2021 |
Pennsaid 1% |
diclofenac sodium |
Horizon |
Akorn |
01/28/2021 |
Ranexa |
ranolazine |
Gilead |
Graviti Pharms |
01/28/2021 |
K-Tab |
potassium chloride |
AbbVie |
AMTA |
01/29/2021 |
Methylin |
methylphenidate hydrochloride |
SpecGx |
Ascent Pharms |
01/29/2021 |
Sabril |
vigabatrin |
Lundbeck |
Dr Reddys Labs |
01/29/2021 |
Levophed |
norepinephrine bitartrate |
Hospira |
Sun |
01/29/2021 |
Foscavir |
foscarnet sodium |
Clinigen |
Fresenius Kabi USA |
01/29/2021 |
Potassium Chloride |
potassium chloride |
Genus |
Granules |
01/29/2021 |
Narcan |
naloxone hydrochloride |
Adapt |
Baxter Healthcare |
02/01/2021 |
Qudexy XR |
topiramate |
Upsher-Smith |
Glenmark |
02/01/2021 |
Prevacid |
lansoprazole |
Takeda |
Dr Reddys Labs |
02/01/2021 |
Noxafil |
posaconazole |
Merck |
Aet Pharma |
02/02/2021 |
Seroquel XR |
quetiapine fumarate |
AstraZeneca |
Mylan |
02/02/2021 |
Latuda |
lurasidone HCl |
Sunovion |
Teva |
02/02/2021 |
Detrol LA |
tolterodine tartrate |
Pfizer |
AMTA |
02/03/2021 |
Kerydin |
tavaborole |
Anacor |
Identirx |
02/05/2021 |
Crestor |
rosuvastatin calcium |
IPR |
Inventia |
02/05/2021 |
Triamcinolone Acetonide |
triamcinolone acetonide |
Mylan |
Perrigo |
02/05/2021 |
Dermotic |
fluocinolone acetonide |
Hill |
Tasman Pharma |
02/05/2021 |
Urocit-K |
potassium citrate |
Mission |
Ascent Pharms |
02/08/2021 |
Kerydin |
tavaborole |
Anacor |
Lupin |
02/08/2021 |
Embeline |
clobetasol propionate |
Akorn |
Prinston |
02/09/2021 |
Nebcin |
tobramycin sulfate |
Eli Lilly |
Gland Pharma |
02/09/2021 |
Linzess |
linaclotide |
AbbVie |
Mylan |
02/09/2021 |
Isuprel |
isoproterenol HCl |
Bausch & Lomb |
Aurobindo |
02/09/2021 |
Kerydin |
tavaborole |
Anacor |
Cipla |
02/09/2021 |
Jadenu Sprinkle |
deferasirox |
Novartis |
Amneal |
02/10/2021 |
Tricor |
fenofibrate |
AbbVie |
AustarPharma |
02/10/2021 |
Sterile Water for Injection |
sterile water for injection |
Hospira |
Nephron |
02/10/2021 |
Lotemax |
loteprednol etabonate |
Bausch & Lomb |
Akorn |
02/10/2021 |
Vigamox |
moxifloxacin HCl |
Novartis |
Upsher-Smith |
02/10/2021 |
Cleocin T-gel |
clindamycin phosphate |
Pfizer |
Glenmark |
02/10/2021 |
Myfortic |
mycophenolic acid |
Novartis |
AMTA |
02/11/2021 |
Marcaine |
bupivacaine HCl |
Hospira |
Hikma |
02/11/2021 |
Marcaine HCL |
bupivacaine HCl |
Hospira |
Hikma |
02/11/2021 |
Deltasone |
prednisone |
Pharmacia |
Strides |
02/11/2021 |
Nebcin |
tobramycin sulfate |
Eli Lilly |
Gland Pharma |
02/11/2021 |
Remodulin |
treprostinil |
United Therapeutics |
Alembic Global |
02/11/2021 |
Cymbalta |
duloxetine HCl |
Eli Lilly |
Sunshine |
02/11/2021 |
Westcort |
hydrocortisone valerate |
Sun |
Cosette |
02/11/2021 |
Afinitor |
everolimus |
Novartis |
Biocon Pharma |
02/12/2021 |
Toprol-XL |
metoprolol succinate |
Toprol Acquisition |
Yichang Humanwell |
02/12/2021 |
Amicar |
aminocaproic acid |
Akorn |
Leading Pharma |
02/16/2021 |
Zosyn |
piperacillin / tazobactam |
Wyeth |
Sagent Pharms |
02/16/2021 |
Isuprel |
isoproterenol HCl |
Bausch & Lomb |
Micro Labs |
02/16/2021 |
Paxil CR |
paroxetine HCl |
Apotex |
CSPC Ouyi |
02/16/2021 |
Klor-Con |
potassium chloride |
Upsher-Smith |
Granules |
02/17/2021 |
Imitrex |
sumatriptan |
Glaxo |
Florida |
02/17/2021 |
Otezla |
apremilast |
Amgen |
Unichem |
02/18/2021 |
Strattera |
atomoxetine HCl |
Eli Lilly |
Mylan |
02/18/2021 |
Dymista |
azelastine HCl / fluticasone propionate |
Mylan/Cipla |
Perrigo |
02/18/2021 |
Northera |
droxidopa |
Lundbeck |
Lupin |
02/18/2021 |
Northera |
droxidopa |
Lundbeck |
Annora |
02/18/2021 |
Northera |
droxidopa |
Lundbeck |
MSN |
02/18/2021 |
Northera |
droxidopa |
Lundbeck |
Zydus |
02/18/2021 |
Northera |
droxidopa |
Lundbeck |
Hikma |
02/18/2021 |
Northera |
droxidopa |
Lundbeck |
Teva |
02/18/2021 |
Northera |
droxidopa |
Lundbeck |
Tasman Pharma |
02/18/2021 |
Northera |
droxidopa |
Lundbeck |
Alkem Labs |
02/18/2021 |
Northera |
droxidopa |
Lundbeck |
Sciegen Pharms |
02/18/2021 |
Northera |
droxidopa |
Lundbeck |
Sun |
02/18/2021 |
Northera |
droxidopa |
Lundbeck |
Aurobindo |
02/18/2021 |
Northera |
droxidopa |
Lundbeck |
Ajanta Pharma |
02/19/2021 |
Omnicef |
cefdinir |
AbbVie |
Alkem Labs |
02/19/2021 |
Suprax |
cefixime |
Lupin |
Alkem Labs |
02/19/2021 |
Elavil |
amitriptyline HCl |
AstraZeneca |
Mankind Pharma |
02/19/2021 |
Urocit-K |
potassium citrate |
Mission |
Eywa |
02/22/2021 |
Diamox |
acetazolamide |
Teva |
Appco |
02/22/2021 |
Motrin |
ibuprofen |
McNeil |
Strides Pharma |
02/22/2021 |
Imitrex |
sumatriptan |
Glaxo |
Cipla |
02/23/2021 |
Banzel |
rufinamide |
Eisai |
Alkem Labs |
02/23/2021 |
Excedrin Migraine |
acetaminophen / aspirin / caffeine |
Glaxo |
Granules |
02/24/2021 |
Periactin |
cyproheptadine HCl |
Merck |
Quagen |
02/24/2021 |
Pamelor |
nortriptyline HCl |
SpecGx |
Zydus |
02/25/2021 |
Zamfeny |
ethinyl estradiol / norelgestromin |
Johnson & Johnson |
Amneal |
02/26/2021 |
Nexium |
esomeprazole magnesium |
AstraZeneca |
Indchemie Health |
02/26/2021 |
Lotemax |
loteprednol etabonate |
Bausch & Lomb |
Sun |
03/01/2021 |
Hysingla ER |
hydrocodone bitartrate |
Purdue |
Alvogen Pine Brook |
03/01/2021 |
Sinequan |
doxepin HCl |
Pfizer |
Leading Pharma |
03/01/2021 |
Prolixin |
fluphenazine HCl |
Bristol-Myers Squibb |
Novitium Pharma |
03/03/2021 |
Valcyte |
valganciclovir HCl |
Hoffmann La Roche |
Mylan |
03/03/2021 |
Methadose |
methadone HCl |
SpecGx |
Lannett |
03/03/2021 |
Emend |
fosaprepitant dimeglumine |
Merck |
Chia Tai Tianqing |
03/03/2021 |
Androgel |
testosterone |
AbbVie |
Aleor Dermaceuticals |
03/03/2021 |
Tenex |
guanfacine HCl |
Promius |
Unichem |
03/04/2021 |
Zestril |
lisinopril |
Almatica |
Yiling |
03/04/2021 |
Robinul |
glycopyrrolate |
Caspar |
Xiromed |
03/05/2021 |
Afinitor |
everolimus |
Novartis |
Breckenridge |
03/05/2021 |
Gilenya |
fingolimod HCl |
Novartis |
Dr Reddys Labs |
03/05/2021 |
CellCept |
mycophenolate mofetil HCl |
Roche |
Amneal |
03/05/2021 |
Lioresal |
baclofen |
Novartis |
Kartha |
03/08/2021 |
Tepadina |
thiotepa |
Amneal |
Gland Pharma |
03/08/2021 |
Cleocin T-gel |
clindamycin phosphate |
Pfizer |
Perrigo |
03/09/2021 |
Saphris |
asenapine maleate |
Breckenridge |
Breckenridge |
03/09/2021 |
Questran |
cholestyramine |
Bristol-Myers Squibb |
Tagi |
03/09/2021 |
Vivlodex |
meloxicam |
iCeutica |
Novitium Pharma |
03/09/2021 |
Sinequan |
doxepin HCl |
Pfizer |
Leading Pharma |
03/09/2021 |
Tobrex |
tobramycin |
Novartis |
Gland Pharma |
03/09/2021 |
Potassium chloride in dextrose and sodium chloride |
Potassium chloride in dextrose and sodium chloride |
ICU Medical |
Fresenius Kabi USA |
03/09/2021 |
Glumetza |
metformin HCl |
Bausch & Lomb |
Ajanta Pharma |
03/09/2021 |
Jadenu Sprinkle |
deferasirox |
Novartis |
Aucta |
03/10/2021 |
Naprosyn |
naproxen |
Atnahs |
Novitium Pharma |
03/10/2021 |
Vibra-Tabs |
doxycycline hyclate |
Pfizer |
Oryza |
03/11/2021 |
Strattera |
atomoxetine HCl |
Eli Lilly |
Hetero Labs |
03/11/2021 |
Ranexa |
ranolazine |
Gilead |
Amneal |
03/11/2021 |
Klor-Con |
potassium chloride |
Upsher-Smith |
Strides Pharma |
03/11/2021 |
Cleocin T-gel |
clindamycin phosphate |
Pfizer |
Encube |
03/12/2021 |
BiNCU |
carmustine |
Emcure |
Jiangsu Hengrui Med |
03/12/2021 |
Lincocin |
lincomycin HCl |
Pfizer |
Praxgen |
03/12/2021 |
Rapamune |
sirolimus |
Pfizer |
Alkem |
03/15/2021 |
Aloxi |
palonosetron HCl |
Roche |
Accord Healthcare |
03/15/2021 |
Depakote ER |
divalproex sodium |
AbbVie |
AMTA |
03/17/2021 |
Zithromax |
azithromycin |
Pfizer |
Yung Shin Pharm |
03/17/2021 |
Jadenu Sprinkle |
deferasirox |
Novartis |
MSN |
03/18/2021 |
Potassium Chloride |
potassium chloride |
ICU Medical |
Nexus Pharms |
03/19/2021 |
Travatan Z |
travoprost |
Novartis |
Micro Labs |
03/19/2021 |
Nexium |
esomeprazole magnesium |
AstraZeneca |
Graviti Pharms |
03/22/2021 |
Cardizem SR |
diltiazem HCl |
Bausch & Lomb |
Glenmark |
03/23/2021 |
Thorazine |
chlorpromazine HCl |
Glaxo |
Glenmark |
03/25/2021 |
Hemabate |
carboprost tromethamine |
Pfizer |
Sunny Pharmtech |
03/25/2021 |
Clobex |
clobetasol propionate |
Galderma |
Taro Pharms |
03/26/2021 |
Dextrose 50% |
dextrose 50% |
Hospira |
Int'l Medication Sys |
03/26/2021 |
Tecfidera |
dimethyl fumarate |
Biogen |
Pharmathen |
03/26/2021 |
Cormax |
clobetasol propionate |
Akorn |
Glasshouse Pharms |
03/26/2021 |
Invanz |
ertapenem sodium |
Merck |
Gland Pharma |
03/29/2021 |
Jublia |
efinaconazole |
Bausch & Lomb |
Aurobindo |
03/29/2021 |
Ferriprox |
deferiprone |
Chiesi |
Hikma |
03/29/2021 |
Arava |
leflunomide |
Sanofi Aventis |
Aurobindo |
03/29/2021 |
Quelicin |
succinylcholine chloride |
Hospira |
Sagent Pharms |
03/30/2021 |
Kuvan |
sapropterin dihydrochloride |
Biomarin |
Dr Reddys Labs |
03/30/2021 |
Mepron |
atovaquone |
Glaxo |
Bionpharma |
03/30/2021 |
Zaroxolyn |
metolazone |
Lannett |
Innogenix |
03/30/2021 |
Zaroxolyn |
metolazone |
Lannett |
Bayshore Pharms |
03/31/2021 |
Nexium |
esomeprazole magnesium |
AstraZeneca |
Ethypharm |
03/31/2021 |
Absorica |
isotretinoin |
Sun |
Actavis |
03/31/2021 |
Imbruvica |
ibrutinib |
Johnson & Johnson |
Zydus |
03/31/2021 |
Klor-Con |
potassium chloride |
Upsher-Smith |
Aurobindo |
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