ANDA Approvals

505(b)(2) Applications and New Drug Applications

Summer 2020

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

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.

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
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