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