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ANDA Approvals
First Quarter
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 |
|---|---|---|---|---|
| 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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