[co-author: Haroon Mian]
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.
--> Scroll to see full table data
Approval Date |
Reference Listed Drug |
Generic Drug Name |
NDA Holder |
ANDA Applicant |
04/01/2020 |
Nexium |
esomeprazole sodium |
AstraZeneca |
Gland Pharma |
04/01/2020 |
Lamictal XR |
lamotrigine |
GlaxoSmithKline |
Zydus |
04/01/2020 |
Crestor |
rosuvastatin calcium |
AstraZeneca |
Sunshine Lake |
04/02/2020 |
heparin sodium preservative free |
heparin sodium preservative free |
Fresenius Kabi |
Nanjing King-Friend |
04/03/2020 |
Adderall |
dextroamp saccharate / amp aspartate / dextroamp sulfate / amp sulfate |
Teva |
Bionpharma |
04/03/2020 |
Anafril |
clomipramine HCl |
SpecGx |
Tulex Pharms |
04/03/2020 |
Namenda |
memantine HCl |
Allergan |
Ningbo |
04/06/2020 |
Trilafon |
perphenazine |
Schering |
Zydus |
04/06/2020 |
Brilinta |
ticagrelor |
AstraZeneca |
Hec Pharm |
04/06/2020 |
Questran |
cholestyramine |
Bristol-Myers Squibb |
Ajanta Pharma |
04/06/2020 |
Ditropan |
oxybutynin chloride |
Janssen |
Leading Pharma |
04/07/2020 |
Brilinta |
ticagrelor |
AstraZeneca |
Sigmapharm Labs |
04/07/2020 |
Minastrin 24 FE |
ethinyl estradiol / norethindrone acetate |
Allergan |
Teva |
04/07/2020 |
Zovirax |
acyclovir |
Bausch & Lomb |
Solaris Pharma |
04/07/2020 |
Elavil |
amitriptyline HCl |
AstraZeneca |
Upsher Smith Labs |
04/07/2020 |
Plaquenil |
hydroxychloroquine sulfate |
Advanz |
Accord Healthcare |
04/08/2020 |
Proventil HFA |
albuterol sulfate |
Merck |
Cipla |
04/08/2020 |
Eliquis |
apixaban |
Bristol-Myers Squibb |
Bionpharma |
04/08/2020 |
Gleevec |
imatinib mesylate |
Novartis |
Zydus |
04/08/2020 |
Prozac |
fluoxetine HCl |
Eli Lilly |
Aurobindo |
04/08/2020 |
butalbital / acetaminophen / caffeine |
butalbital / acetaminophen / caffeine |
Nexgen |
Granules Pharms |
04/08/2020 |
Hydera |
hydroxyurea |
Bristol-Myers Squibb |
Leading Pharma |
04/09/2020 |
Naropin |
ropivacaine HCl |
Fresenius Kabi |
Caplin |
04/09/2020 |
Renvela |
sevelamer carbonate |
Genzyme |
Anxin |
04/09/2020 |
Glumetza |
metformin HCl |
Santarus |
Ajanta Pharma |
04/10/2020 |
Methylin |
methylphenidate HCl |
SpecGx |
Patrin Pharma |
04/10/2020 |
Rozarem |
ramelteon |
Takeda |
I3 Pharms |
04/13/2020 |
Benicar |
olmesartan medoxomil |
Daiichi Sankyo |
Sandoz |
04/13/2020 |
Soolantra |
ivermectin |
Galderma |
Perrigo |
04/13/2020 |
Vesicare |
solifenacin succinate |
Astellas |
Sunshine Lake |
04/13/2020 |
Aromasin |
exemestane |
Pfizer |
Qilu |
04/14/2020 |
Butrans |
buprenorphine |
Purdue |
Amneal |
04/15/2020 |
Estrostep FE |
ethinyl estradiol / norethindrone acetate |
Allergan |
Novast Labs |
04/15/2020 |
Tegretol |
carbamazepine |
Novartis |
Umedica Labs |
04/16/2020 |
Androgel |
testosterone |
AbbVie |
Xiromed |
04/16/2020 |
Tarceva |
erlotinib HCl |
OSI Pharma |
Zydus |
04/17/2020 |
Wellbutrin |
bupropion HCl |
GlaxoSmithKline |
Micro Labs |
04/17/2020 |
Suboxone |
buprenorphine HCl / naloxone HCl |
Indivior |
Mylan |
04/17/2020 |
Ancoban |
flucytosine |
Bausch & Lomb |
Strides Pharma |
04/17/2020 |
Bromfed DM |
brompheniramine maleate / pseudoephedrine HCl / dextromethorphan hydrobromide |
Wockhardt |
Lannett |
04/20/2020 |
AccuNeb |
albuterol sulfate |
Mylan |
Aurobindo |
04/20/2020 |
Welchol |
colesevelam HCl |
Daiichi Sankyo |
Invagen Pharms |
04/21/2020 |
Delestrogen |
estradiol valerate |
Par |
Hikma |
04/21/2020 |
Cloderm |
clocortolone pivalate |
EPI |
Taro |
04/22/2020 |
Levaquin |
levofloxacin |
Janssen |
Gland Pharma |
04/22/2020 |
Dilaudid |
hydromorphone HCl |
Rhodes |
Lannett |
04/23/2020 |
Viagra |
sildenafil citrate |
Pfizer |
Perrigo |
04/23/2020 |
Sodium Chloride |
sodium chloride 0.9% in plastic container |
Hospira |
Nephron |
04/23/2020 |
Zovirax |
acyclovir |
Bausch & Lomb |
Heritage Pharms |
04/23/2020 |
Sanctura XR |
trospium chloride |
Allergan |
Granules Pharms |
04/24/2020 |
Jadenu |
deferasirox |
Novartis |
Teva |
04/24/2020 |
Tegretol XR |
carbamazepine |
Novartis |
Unique Pharm |
04/24/2020 |
Adrenalin |
epinephrine |
Par |
Intl Medication Sys |
04/24/2020 |
Onfi |
clobazam |
Lundbeck |
Lannett |
04/24/2020 |
Sabril |
vigabatrin |
Lundbeck |
Granules Pharms |
04/27/2020 |
Bactroban |
mupirocin |
GlaxoSmithKline |
Taro |
04/27/2020 |
Xeloda |
capecitabine |
Hoffmann LaRoche |
Reliance Life |
04/28/2020 |
Tiazac |
diltiazem HCl |
Bausch & Lomb |
Accord Healthcare |
04/28/2020 |
Mucinex D |
guaifenesin / pseudoephedrine HCl |
Reckitt Benckiser |
Sun Pharm Inds |
04/28/2020 |
Cuprimine |
penicillamine |
Bausch |
Apotex |
04/29/2020 |
oxycodone HCl |
oxycodone HCl |
Genus Life |
Rhodes Pharms |
04/29/2020 |
Xyzal Allergy 24HR |
levocetirizine dihydrochloride |
UCB |
Hetero Labs |
04/30/2020 |
Diamox |
acetazolamide |
Teva |
Breckenridge |
04/30/2020 |
Lidoderm |
lidocaine |
Teikoku Pharma USA |
Rhodes Pharms |
04/30/2020 |
Zegerid |
omeprazole / sodium bicarbonate |
Bayer |
Guardian Drug |
05/01/2020 |
Methergine |
methylergonovine maleate |
Edison Therapeutics |
Tulex Pharms |
05/01/2020 |
Minocycline HCl |
minocycline HCl |
Triax Pharma |
Aurobindo |
05/01/2020 |
Ancoban |
flucytosine |
Bausch & Lomb |
Aurobindo |
05/04/2020 |
Nimbex |
cisatracurium besylate |
AbbVie |
Piramal Healthcare |
05/04/2020 |
Nexium 24HR |
esomeprazole magnesium |
AstraZeneca |
Sun Pharm |
05/04/2020 |
Anectine/Quelicin |
succinylcholine chloride |
Hospira/Sandoz |
Aspiro |
05/05/2020 |
Exjade |
deferasirox |
Novartis |
Zydus |
05/06/2020 |
Pradaxa |
dabigatran etexilate mesylate |
BI |
Hetero Labs |
05/06/2020 |
Sklice |
ivermectin |
Arbor |
Taro |
05/07/2020 |
Xylocaine |
lidocaine HCl |
Fresenius Kabi |
Huons |
05/08/2020 |
Actigall |
ursodiol |
Allergan |
Nexgen Pharma |
05/08/2020 |
Nimbex |
cisatracurium besylate |
AbbVie |
Aurobindo |
05/08/2020 |
Alkeran |
melphalan HCl |
Apotex |
Bpi Labs |
05/08/2020 |
Zithromax |
azithromycin |
Pfizer |
Yung Shin Pharm |
05/08/2020 |
Astelin |
azelastine HCl |
Mylan |
Aurobindo |
05/08/2020 |
Klor-Con |
potassium chloride |
Upsher-Smith |
Amneal |
05/08/2020 |
Mucinex |
guaifenesin |
Reckitt Benckiser |
Granules India |
05/08/2020 |
Motrin |
ibuprofen |
McNeil |
Aurobindo |
05/11/2020 |
Desonate |
desonide |
Bayer |
Teresina |
05/11/2020 |
Taclonex |
calcipotriene / betamethasone dipropionate |
LEO Pharma |
Tolmar |
05/11/2020 |
Luvox CR |
fluvoxamine maleate |
Elan |
Bionpharma |
05/12/2020 |
Lovaza |
omega-3-acid ethyl esters |
GlaxoSmithKline |
Cspc Nbp Pharm |
05/13/2020 |
Elyxb |
celecoxib |
Dr. Reddy's |
Nanjing |
05/14/2020 |
Vibra Tabs |
doxycycline hyclate |
Pfizer |
Alembic Pharms |
05/14/2020 |
Nexium 24HR OTC |
esomeprazole magnesium |
AstraZeneca |
Dr Reddy's |
05/14/2020 |
Nicorette |
nicotine polacrilex |
GlaxoSmithKline |
P and L |
05/14/2020 |
Symfi/Symfi Lo |
efavirenz / lamivudine / tenofovir disoproxil fumarate |
Mylan |
Laurus Labs |
05/14/2020 |
Plaquenil |
hydroxychloroquine sulfate |
Advanz |
Havix |
05/14/2020 |
Proventil |
albuterol sulfate |
Schering |
Aurobindo |
05/15/2020 |
Truvada |
emtricitabine / tenofovir disoproxil fumarate |
Gilead |
Macleods Pharms |
05/15/2020 |
Noxafil |
posaconazole |
Hikma |
Hikma |
05/15/2020 |
Sensipar |
cinacalcet HCl |
Amgen |
Accord Healthcare |
05/18/2020 |
Prevacid |
lansoprazole |
Takeda |
Hetero Labs |
05/18/2020 |
Gilenya |
fingolimod HCl |
Novartis |
Hetero Labs |
05/18/2020 |
Zytiga |
abiraterone acetate |
J&J |
Dr Reddy's |
05/18/2020 |
Benicar |
olmesartan medoxomil |
Daiichi Sankyo |
Inventia |
05/18/2020 |
Clobex |
clobetasol propionate |
Galderma |
Aleor Dermaceuticals |
05/18/2020 |
Sensipar |
cinacalcet HCl |
Amgen |
Acme Labs |
05/19/2020 |
Samsca |
tolvaptan |
Otsuka |
Apotex |
05/19/2020 |
Anectine/Quelicin |
succinylcholine chloride |
Hospira/Sandoz |
Nivagen Pharms |
05/19/2020 |
Samsca |
tolvaptan |
Otsuka |
Alkem Labs |
05/19/2020 |
Detrol LA |
tolterodine tartrate |
Pfizer |
Ajanta Pharma |
05/20/2020 |
Precedex |
dexmedetomidine HCl |
Hospira |
Amneal |
05/20/2020 |
Pataday |
olopatadine HCl |
Novartis |
Gland Pharma |
05/20/2020 |
Baraclude |
entecavir |
Bristol-Myers Squibb |
Sunshine Lake |
05/20/2020 |
Tamiflu |
oseltamivir phosphate |
Roche |
MSN |
05/20/2020 |
Migranal |
dihydroergotamine mesylate |
Bausch |
Cipla |
05/20/2020 |
Anectine/Quelicin |
succinylcholine chloride |
Hospira/Sandoz |
Accord Healthcare |
05/21/2020 |
Vascepa |
icosapent ethyl |
Amarin |
Hikma |
05/21/2020 |
Syprine |
trientine HCl |
Bausch & Lomb |
Lupin |
05/21/2020 |
Symmetrel |
amantadine HCl |
Endo Pharma |
Rubicon |
05/22/2020 |
Aloxi |
palonosetron HCl |
Helsinn |
Ingenus Pharms |
05/22/2020 |
Remodulin |
treprostinil |
United Therapeutics |
Dr Reddy's |
05/22/2020 |
Bentyl |
dicyclomine HCl |
Aptalis |
Hikma |
05/22/2020 |
Evekeo |
amphetamine sulfate |
Arbor |
Havix |
05/22/2020 |
Anectine/Quelicin |
succinylcholine chloride |
Hospira/Sandoz |
Indoco Remedies |
05/26/2020 |
Chlorzoxazone |
chlorzoxazone |
Mikart |
Glenmark Pharms |
05/27/2020 |
Tamiflu |
oseltamivir phosphate |
Gilead |
Ajanta Pharma |
05/27/2020 |
Zanaflex |
tizanidine HCl |
Covis Pharma |
Rubicon |
05/28/2020 |
Cosopt |
dorzolamide HCl / timolol maleate |
Oak Pharma |
Micro Labs |
05/28/2020 |
Nexium 24HR OTC |
esomeprazole magnesium |
AstraZeneca |
Hetero Labs |
05/29/2020 |
Revatio |
sildenafil citrate |
Pfizer |
Teva |
06/01/2020 |
Alaway/Zaditor |
ketotifen fumarate |
Bausch/Novartis |
Bayshore Pharms |
06/01/2020 |
Prilosec OTC |
omeprazole magnesium |
AstraZeneca |
P and L |
06/01/2020 |
Vivlodex |
meloxicam |
iCeutica |
Lupin |
06/01/2020 |
Reyataz |
atazanavir sulfate |
Bristol-Myers Squibb |
Amneal |
06/01/2020 |
Acticlate |
doxycycline hyclate |
Almirall |
Ajanta Pharma |
06/01/2020 |
Magnesium Sulfate |
magnesium sulfate in plastic container |
Hospira |
Baxter Healthcare |
06/01/2020 |
Triamcinolone 0.05% ointment |
triamcinolone acetonide |
CMP |
Strides Pharma |
06/02/2020 |
Unipen |
nafcillin sodium |
Wyeth |
Fresenius Kabi USA |
06/02/2020 |
Nexium |
esomeprazole magnesium |
AstraZeneca |
Hetero Labs |
06/02/2020 |
Uloric |
febuxostat |
Takeda |
Sunshine Lake |
06/03/2020 |
Precedex |
dexmedetomidine HCl |
Hospira |
Gland Pharma |
06/03/2020 |
Lomotil |
diphenoxylate HCl / atropine sulfate |
Pfizer |
Mayne Pharma |
06/03/2020 |
Ultravate lotion 0.05% |
halobetasol propionate |
Sun |
Perrigo |
06/04/2020 |
Reyataz |
atazanavir sulfate |
Bristol-Myers Squibb |
Zydus |
06/04/2020 |
Methylin |
methylphenidate HCl |
SpecGx |
Quagen |
06/04/2020 |
Ambien CR |
zolpidem tartrate |
Sanofi |
Centaur Pharms |
06/05/2020 |
Hexadrol |
dexamethasone sodium phosphate |
Aspen Global |
Aurobindo |
06/05/2020 |
Vazculep |
phenylephrine HCl |
Avadel |
Gland Pharma |
06/08/2020 |
Afinitor |
everolimus |
Novartis |
Hikma |
06/08/2020 |
Vidaza |
azacitidine |
Celgene |
Eurohealth Intl |
06/08/2020 |
Afinitor |
everolimus |
Novartis |
Mylan |
06/08/2020 |
Anectine/Quelicin |
succinylcholine chloride |
Hospira/Sandoz |
Amphastar Pharms |
06/09/2020 |
Edecrin |
ethacrynate sodium |
Bausch |
VPI Pharms |
06/09/2020 |
Onfi |
clobazam |
Lundbeck |
Apotex |
06/10/2020 |
Albenza |
albendazole |
Amneal |
Lupin |
06/10/2020 |
Prozac |
fluoxetine hydrochloride |
Eli Lilly |
Aurobindo |
06/11/2020 |
Keppra XR |
levetiracetam |
UCB |
Overseas |
06/11/2020 |
Viagra |
sildenafil citrate |
Pfizer |
Sunshine Lake |
06/11/2020 |
Vazculep |
phenylephrine hydrochloride |
Avadel |
Caplin |
06/12/2020 |
Viagra |
sildenafil citrate |
Pfizer |
Reyoung |
06/12/2020 |
Anectine/Quelicin |
succinylcholine chloride |
Hospira/Sandoz |
Hikma |
06/12/2020 |
Tricor |
fenofibrate |
AbbVie |
Mankind Pharma |
06/15/2020 |
Lovaza |
omega-3-acid ethyl esters |
GlaxoSmithKline |
Puracap Pharm |
06/15/2020 |
Jadenu |
deferasirox |
Novartis |
Amneal |
06/15/2020 |
Jadenu |
deferasirox |
Novartis |
Zydus |
06/15/2020 |
Jadenu |
deferasirox |
Novartis |
Sun Pharm |
06/15/2020 |
Jadenu |
deferasirox |
Novartis |
Alembic Pharms |
06/15/2020 |
Jadenu |
deferasirox |
Novartis |
Cipla |
06/15/2020 |
Jadenu |
deferasirox |
Novartis |
Piramal Healthcare |
06/16/2020 |
Targretin |
bexarotene |
Bausch & Lomb |
Hikma |
06/16/2020 |
Pataday |
olopatadine HCl |
Novartis |
Micro Labs |
06/16/2020 |
Jadenu |
deferasirox |
Novartis |
MSN |
06/16/2020 |
Bromfed DM |
brompheniramine maleate / pseudoephedrine HCl / dextromethorphan hydrobromide |
Wockhardt |
Wes Pharma |
06/16/2020 |
Meticorten |
prednisone |
Schering |
Amneal |
06/16/2020 |
Trilipix |
fenofibric acid |
Novartis |
Micro Labs |
06/16/2020 |
Anectine/Quelicin |
succinylcholine chloride |
Hospira/Sandoz |
Gland Pharma |
06/17/2020 |
Zovirax |
acyclovir sodium |
GlaxoSmithKline |
Exela Pharma Scs |
06/17/2020 |
Aubagio |
teriflunomide |
Sanofi |
Impax |
06/17/2020 |
Sernivo |
betamethasone dipropionate |
Encore |
Taro Pharms |
06/17/2020 |
Parafone Forte |
chlorzoxazone |
J&J |
Teva |
06/18/2020 |
Gilenya |
fingolimod HCl |
Novartis |
Glenmark |
06/18/2020 |
Firazyr |
icatibant acetate |
Shire |
Fresenius Kabi USA |
06/18/2020 |
Rythmol SR |
propafenone HCl |
Glaxo |
Twi |
06/18/2020 |
Differin |
adapalene |
Galderma |
Aleor Dermaceuticals |
06/19/2020 |
Cotempla XR ODT |
methylphenidate |
Neos |
Actavis |
06/19/2020 |
Brethine |
terbutaline sulfate |
ANI |
Twi |
06/19/2020 |
Tikosyn |
dofetilide |
Pfizer |
Accord Hlthcare |
06/22/2020 |
Anafril |
clomipramine HCl |
SpecGx |
Micro Labs |
06/22/2020 |
Anafril |
clomipramine HCl |
SpecGx |
Vgyaan |
06/23/2020 |
Lipitor |
atorvastatin calcium |
Pfizer |
Perrigo |
06/23/2020 |
Antivert |
meclizine HCl |
Casper |
Zydus |
06/24/2020 |
Adderall |
dextroamp saccharate / amp aspartate / dextroamp sulfate / amp sulfate |
Shire |
Mylan |
06/24/2020 |
Deltasone |
prednisone |
Pharmacia and Upjohn |
Amneal |
06/25/2020 |
Amoxil |
amoxicillin |
Neopharma |
Hikma |
06/25/2020 |
Nexium 24HR OTC |
esomeprazole magnesium |
AstraZeneca |
Mylan |
06/25/2020 |
Rythmol SR |
propafenone HCl |
Glaxo |
Upsher Smith Labs |
06/26/2020 |
Cytarabine |
cytarabine |
Hospira |
Hong Kong |
06/29/2020 |
Kytril |
granisetron HCl |
Hoffmann LaRoche |
Yung Shin Pharm |
06/29/2020 |
Gilenya |
fingolimod HCl |
Novartis |
Strides Pharma |
06/29/2020 |
Urocit K |
potassium citrate |
Mission |
Bionpharma |
06/30/2020 |
Acticlate |
doxycycline hyclate |
Almirall |
Alembic Pharms |
06/30/2020 |
Protonix |
pantoprazole sodium |
Wyeth |
Sun Pharm |
--> Scroll to see full table data