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 |
|---|---|---|---|---|
| 07/01/2020 | butalbital / acetaminophen / caffeine | butalbital / acetaminophen / caffeine | LGM Pharma | Taro Pharm |
| 07/01/2020 | Sinequan | doxepin HCl | Pfizer | Taro Pharm |
| 07/01/2020 | Vazculep | phenylephrine HCl | Avadel | Accord Hlthcare |
| 07/01/2020 | Levo-Dromoran | levorphanol tartrate | Valeant | Novitium Pharma |
| 07/01/2020 | Kenalog | triamcinolone acetonide | Delcor | Quagen |
| 07/01/2020 | Furosemide | furosemide | Amercian Regent | Gland Pharma |
| 07/02/2020 | Gilenya | fingolimod HCl | Novartis | Teva |
| 07/02/2020 | Jadenu | deferasirox | Novartis | Alkem Labs |
| 07/02/2020 | Tarceva | erlotinib HCl | Genentech | Accord Healthcare |
| 07/06/2020 | Ampyra | dalfampridine | Acorda | Mylan |
| 07/06/2020 | Diclegis | doxylamine succinate / pyridoxine HCl | Duchesnay | Mylan |
| 07/06/2020 | Isoptin | verapamil HCl | Mt Adams | Aurobindo |
| 07/06/2020 | Flexeril | cyclobenzaprine HCl | Johnson & Johnson | Unichem |
| 07/06/2020 | Levetiracetam in Sodium Chloride | levetiracetam in sodium chloride | HQ Specialty | Nexus Pharms |
| 07/07/2020 | Effient | prasugrel | Eli Lilly | Dr Reddys |
| 07/07/2020 | Librax | chlordiazepoxide HCl / clidinium bromide | Bausch & Lomb | Nuvo Pharms |
| 07/07/2020 | Thorazine | chlorpromazine HCl | Glaxo | Aurobindo |
| 07/08/2020 | Fioricet with codeine | butalbital / acetaminophen / caffeine / codeine phosphate | Teva | Strides |
| 07/08/2020 | Proglycem | diazoxide | Teva | Novitium Pharma |
| 07/08/2020 | Robinul | glycopyrrolate | Hikma | Accord Healthcare |
| 07/09/2020 | Lyrica | pregabalin | Pfizer | Actavis |
| 07/09/2020 | Duoneb | albuterol sulfate / ipratropium bromide | Mylan | Aurobindo |
| 07/09/2020 | Lioresal | baclofen | Novartis | Unichem |
| 07/09/2020 | Ziac | bisoprolol fumarate / hydrochlorothiazide | Teva | Edenbridge Pharms |
| 07/09/2020 | Permitil | fluphenazine HCl | Schering | Amneal |
| 07/10/2020 | Zovirax | acyclovir | Mylan | Novitium Pharma |
| 07/10/2020 | Magnesium Sulfate in Plastic Container | magnesium sulfate in plastic container | Hospira | Gland Pharma |
| 07/13/2020 | Relpax | eletriptan hydrobromide | Upjohn | Yung Shin Pharm |
| 07/13/2020 | Firazyr | icatibant acetate | Shire | Cipla |
| 07/14/2020 | Bromfed DM | brompheniramine maleate / pseudoephedrine HCl / dextromethorphan hydrobromide | Wockhardt | Alkem Labs |
| 07/14/2020 | Mykacet | nystatin / triamcinolone acetonide | Cossette | Torrent |
| 07/14/2020 | Jadenu Sprinkle | deferasirox | Novartis | Alkem Labs |
| 07/14/2020 | Evekeo | amphetamine sulfate | Arbor | Mayne Pharma |
| 07/14/2020 | Betamethasone Dipropionate | betamethasone dipropionate | Fougera | Cadila |
| 07/15/2020 | Welchol | colesevelam HCl | Daiichi Sankyo | Zhejiang Jingxin |
| 07/15/2020 | Heparin Sodium | heparin sodium | West-Ward | Nanjing King-Friend |
| 07/16/2020 | Percodan | oxycodone and aspirin | Endo | Epic Pharma |
| 07/16/2020 | Primacor in Dextrose 5% in Plastic Container | milrinone lactate in dextrose 5% in plastic container | Sanofi Aventis | Gland Pharma |
| 07/17/2020 | Suboxone | buprenorphine HCl / naloxone HCl | Indivior | Mayne Pharma |
| 07/17/2020 | Suboxone | buprenorphine HCl / naloxone HCl | Indivior | Wes Pharma |
| 07/17/2020 | Vazculep | phenylephrine HCl | Avadel | Apollo |
| 07/17/2020 | butalbital / acetaminophen / caffeine | butalbital / acetaminophen / caffeine | Vintage | Nesher Pharms |
| 07/17/2020 | Plavix | clopidogrel bisulfate | Bristol-Myers Squibb | Polygen Pharms |
| 07/20/2020 | Oxacillin Sodium | oxacillin sodium | Bristol-Myers Squibb | Fresenius Kabi |
| 07/20/2020 | Naropin | ropivacaine HCl | Fresenius Kabi | Hikma |
| 07/20/2020 | Wynzora | betamethasone dipropionate / calcipotriene | MC2 Therapeutics | MC2 Therapeutics |
| 07/21/2020 | Parafone Forte | chlorzoxazone | Mikart | Mayne Pharma |
| 07/21/2020 | Maxipime | cefepime HCl | Hospira | Astral |
| 07/21/2020 | Cordarone | amiodarone HCl | Wyeth | Unichem |
| 07/22/2020 | Mexitil | mexiletine HCl | Boehringer Ingelheim | Crossmedika |
| 07/23/2020 | Ritalin | methylphenidate HCl | Novartis | Prinston Inc |
| 07/23/2020 | Gleevec | imatinib mesylate | Novartis | Eugia Pharma |
| 07/24/2020 | Silenor | doxepin HCl | Currax | Par |
| 07/24/2020 | Arimidex | anastrozole | ANI | Eugia Pharma |
| 07/24/2020 | Heparin Sodium 1,000 units in Sodium Chloride 0.9% in Plastic Container | heparin sodium 1,000 units in sodium chloride 0.9% in plastic container | Hospira | Fresenius Kabi |
| 07/24/2020 | Heparin Sodium 2,000 units in Sodium Chloride 0.9% in Plastic Container | heparin sodium 2,000 units in sodium chloride 0.9% in plastic container | Hospira | Fresenius Kabi |
| 07/24/2020 | Sinequan | doxepin HCl | Pfizer | Lannett |
| 07/24/2020 | Demser | metyrosine | Bausch & Lomb | Amneal |
| 07/27/2020 | Oxacillin Sodium | oxacillin sodium | Bristol-Myers Squibb | Fresenius Kabi |
| 07/28/2020 | Eliquis | apixaban | Bristol-Myers Squibb | Accord Healthcare |
| 07/28/2020 | Sinequan | doxepin hydrochloride | Pfizer | Contract Pharmacal |
| 07/29/2020 | Tasmar | tolcapone | Bausch & Lomb | Alvogen |
| 07/29/2020 | Librax | chlordiazepoxide HCl / clidinium bromide | Bausch & Lomb | Misemer |
| 07/29/2020 | Cleocin T | clindamycin phosphate | Pfizer | Solaris Pharma |
| 07/29/2020 | Concerta | methylphenidate HCl | Johnson & Johnson | Dr Reddys |
| 07/30/2020 | Wellcovorin | leucovorin calcium | Glaxo | Novast Labs |
| 07/30/2020 | Cyclophosphamide | cyclophosphamide | Ingenus | Ingenus |
| 07/31/2020 | Zyprexa | olanzapine | Eli Lilly | Indoco |
| 07/31/2020 | CellCept | mycophenolate mofetil | Roche | Concord Biotech |
| 07/31/2020 | Naprosyn | naproxen | Atnahs Pharma | Amneal |
| 08/03/2020 | Korlym | mifepristone | Corcept | Teva |
| 08/03/2020 | Metro I.V. | metronidazole in plastic container | B. Braun | Gland Pharma |
| 08/03/2020 | Vasostrict | vasopressin | Par | American Reagent |
| 08/04/2020 | Akovaz | ephedrine sulfate | Exela | Fresenius Kabi |
| 08/04/2020 | Cuprimine | penicillamine | Bausch & Lomb | Dr Reddys |
| 08/04/2020 | Nicorette | nicotine polacrilex | Glaxo | Dr Reddys |
| 08/04/2020 | Levitra | vardenafil HCl | Bayer | Alembic Pharms |
| 08/05/2020 | Renvela | sevelamer carbonate | Genzyme | Mylan |
| 08/05/2020 | Detrol | tolterodine tartrate | Novartis | Unichem |
| 08/06/2020 | Zavesca | miglustat | Actelion | Edenbridge Pharms |
| 08/06/2020 | Revatio | sildenafil citrate | Pfizer | Aptapharma |
| 08/07/2020 | Faslodex | fulvestrant | AstraZeneca | Dr Reddys |
| 08/07/2020 | Vascepa | icosapent ethyl | Amarin | Dr Reddys |
| 08/07/2020 | Anafranil | clomipramine HCl | SpecGx | Unique Pharm Labs |
| 08/07/2020 | Ofirmev | acetaminophen | Mallinckrodt | Mylan |
| 08/10/2020 | Ciprodex | ciprofloxacin / dexamethasone | Novartis | Dr Reddys |
| 08/10/2020 | Baraclude | entecavir | Bristol-Myers Squibb | Pharmadax |
| 08/10/2020 | Inspra | eplerenone | Pfizer | Piramal |
| 08/10/2020 | Proamatine | midodrine HCl | Takeda | Aurobindo |
| 08/11/2020 | Vancomycin HCl | vancomycin HCl | Baxter | Hikma |
| 08/11/2020 | Renvela | sevelamer carbonate | Genzyme | Zydus |
| 08/11/2020 | Magnesium Sulfate in Dextrose 5% in Plastic Container | magnesium sulfate in dextrose 5% in plastic container | Hospira | Baxter |
| 08/11/2020 | Amicar | aminocaproic acid | Clover | Tulex Pharms |
| 08/12/2020 | Robaxin-750 | methocarbamol | Auxiluim | Aurobindo |
| 08/13/2020 | Stalevo | carbidopa / levodopa / entacapone | Novartis | Mylan |
| 08/14/2020 | Canasa | mesalamine | Allergan | Actavis |
| 08/14/2020 | Nolvadex | tamoxifen citrate | AstraZeneca | Eugia Pharma |
| 08/17/2020 | Alesse | levonorgestrel / ethinyl estradiol | Cadence | Naari PTE |
| 08/17/2020 | Tecfidera | dimethyl fumarate | Biogen | Mylan |
| 08/17/2020 | Actigall | ursodiol | Allergan | Upsher Smith |
| 08/17/2020 | Neurontin | gabapentin | Upjohn | Zhejiang Yongtai |
| 08/18/2020 | Evista | raloxifene HCl | Eli Lilly | Cadila Pharms |
| 08/18/2020 | Farston | toremifene citrate | Kyowa Kirin | MSN |
| 08/18/2020 | Precose | acarbose | Bayer | Hangzhou Zhongmei |
| 08/19/2020 | Concerta | methylphenidate HCl | Johnson & Johnson | Sun |
| 08/19/2020 | Lovaza | omega-3-acid ethyl esters | SmithKline Beecham | GLW |
| 08/19/2020 | Patanase | olopatadine HCl | Novartis | Akorn |
| 08/19/2020 | Lipitor | atorvastatin calcium | Upjohn | Umedica Labs |
| 08/20/2020 | Torodol | ketorolac tromethamine | Roche | Nephron |
| 08/20/2020 | Emend | fosaprepitant dimeglumine | Merck | Navinta |
| 08/20/2020 | Daptomycin | daptomycin | Xellia | Be Pharms |
| 08/20/2020 | Urso/Urso Forte | ursodiol | Allergan | Strides |
| 08/21/2020 | Rozarem | ramelteon | Takeda | Granules Pharms |
| 08/21/2020 | Klor-Con | potassium chloride | Upsher-Smith | Unichem |
| 08/21/2020 | Alimta | pemetrexed | Eli Lilly | Teva |
| 08/24/2020 | Lidoderm patch | lidocaine | Endo | Amneal |
| 08/24/2020 | ProAir HFA | albuterol sulfate | Teva | Lupin |
| 08/24/2020 | Taxol | paclitaxel | HQ Specialty | MSN |
| 08/24/2020 | DesOwen 0.05% lotion | desonide | Galderma | Aleor Dermaceuticals |
| 08/24/2020 | Evekeo | amphetamine sulfate | Arbor | Novast Labs |
| 08/25/2020 | Viagra | sildenafil citrate | Pfizer | Umedica Labs |
| 08/25/2020 | Nitropress | sodium nitroprusside | Hospira | Hainan Poly Pharm |
| 08/26/2020 | Emend | fosaprepitant dimeglumine | Merck | Accord Healthcare |
| 08/26/2020 | Dextrose 5% and Sodium Chloride 0.3% in Plastic Container | dextrose 5% and sodium chloride 0.3% in plastic container | ICU Medical | Fresenius Kabi |
| 08/27/2020 | Prozac | fluoxetine HCl | Eli Lilly | Accord Healthcare |
| 08/27/2020 | Precedex | dexmedetomidine HCl | Hospira | Mylan |
| 08/28/2020 | Cormax | clobetasol propionate | Akorn | Encube |
| 08/31/2020 | Namenda | memantine HCl | Allergan | Saptalis Pharms |
| 08/31/2020 | Cubicin | daptomycin | Cubist | Dr Reddys |
| 08/31/2020 | Thorazine | chlorpromazine HCl | Glaxo | Mayne Pharma |
| 09/01/2020 | Welchol | colesevelam HCl | Genzyme | Watson |
| 09/01/2020 | Fentanyl Citrate | fentanyl citrate | Hospira | Fresenius Kabi |
| 09/01/2020 | Sporanox | itraconazole | Janssen | Annora Pharma |
| 09/01/2020 | Proamatine | midodrine HCl | Takeda | Zydus |
| 09/01/2020 | Nimbex | cisatracurium besylate | AbbVie | Zydus |
| 09/02/2020 | Welchol | colesevelam HCl | Daiichi Sankyo | Watson |
| 09/02/2020 | Meticorten | prednisone | Schering | Strides |
| 09/02/2020 | Firazyr | icatibant acetate | Shire | Slayback Pharma |
| 09/02/2020 | Taclonex | calcipotriene / betamethasone dipropionate | LEO Pharma | Taro |
| 09/03/2020 | Primacor | milrinone lactate in dextrose 5% | Sanofi Aventis | Aurobindo |
| 09/04/2020 | Singulair | montelukast sodium | Merck | Amneal Pharms |
| 09/04/2020 | Sinequan | doxepin HCl | Pfizer | Upsher Smith |
| 09/08/2020 | Lumigan | bimatoprost | Allergan | Micro Labs |
| 09/08/2020 | Emend I.V. | fosaprepitant dimeglumine | Merck | Qilu |
| 09/09/2020 | Potassium Chloride | potassium chloride | Baxter | Fresenius Kabi |
| 09/09/2020 | Ammonia N 13 | ammonia N 13 | Feinstein Institute | Univ Wisconsin |
| 09/09/2020 | Nascobal | cyanocobalamin | Endo | Perrigo |
| 09/09/2020 | Lotronex | alosetron HCl | Sebela | Mankind Pharma |
| 09/09/2020 | Focalin XR | dexmethylphenidate HCl | Novartis | Granules Pharms |
| 09/10/2020 | Nexavar | sorafenib tosylate | Bayer | Mylan |
| 09/10/2020 | Doxil (Liposomal) | doxorubicin HCl | Baxter | Zydus |
| 09/10/2020 | Dextrose 5% and Potassium Chloride 0.075% | dextrose 5% and potassium chloride 0.075% | Baxter | Fresenius Kabi |
| 09/10/2020 | Dextrose 5% and Potassium Chloride 0.15% | dextrose 5% and potassium chloride 0.15% | Baxter | Fresenius Kabi |
| 09/10/2020 | Accolate | zafirlukast | Par | Annora Pharma |
| 09/10/2020 | Claritin | loratadine | Glaxo | Rubicon |
| 09/11/2020 | Vascepa | icosapent ethyl | Amarin | Teva |
| 09/11/2020 | Eliquis | apixaban | Bristol-Myers Squibb | Indoco |
| 09/11/2020 | Timoptic in Ocudose | timolol maleate | Bausch & Lomb | Akorn |
| 09/11/2020 | Taclonex | calcipotriene / bethamethasone dipropionate | LEO Pharma | Perrigo |
| 09/11/2020 | Zyrtec Allergy | cetirizine HCl | Johnson & Johnson | Aurobindo |
| 09/14/2020 | Dextrose 5% and Sodium Chloride 0.9% | dextrose 5% and sodium chloride 0.9% | ICU Medical | Fresenius Kabi |
| 09/14/2020 | Parafone Forte | chlorzoxazone | Mikart | I3 Pharms |
| 09/14/2020 | Zovirax | acyclovir | Mylan | Yiling |
| 09/15/2020 | Hectorol | doxercalciferol | Genzyme | Avet |
| 09/15/2020 | Precedex | dexmedetomidine HCl | Hospira | Par |
| 09/15/2020 | Dextrose 5% and Sodium Chloride 0.225% | dextrose 5% and sodium chloride 0.225% | ICU Medical | Fresenius Kabi |
| 09/15/2020 | Dextrose 5% and Sodium Chloride 0.45% | dextrose 5% and sodium chloride 0.45% | ICU Medical | Fresenius Kabi |
| 09/15/2020 | Zestril | lisinopril | Alvogen | Yiling |
| 09/16/2020 | Diprivan | propofol | Fesenius Kabi | Innopharma |
| 09/16/2020 | Tambocor | flecainide acetate | County Line | Beximco Pharms |
| 09/17/2020 | Uceris | budesonide | Bausch & Lomb | Mylan |
| 09/17/2020 | DDAVP | desmopressin acetate | Ferring | UBI |
| 09/17/2020 | K-Dur | potassium chloride | Upsher-Smith | Zydus Pharms |
| 09/17/2020 | Erythrocin | erythromycin lactobionate | Hospira | Exela Pharma |
| 09/17/2020 | Potassium Chloride 0.15% in Sodium Chloride 0.45% | potassium chloride 0.15% in sodium chloride 0.45% | Baxter | Fresenius Kabi |
| 09/17/2020 | Potassium Chloride 0.3% and Sodium Chloride 0.9% | potassium chloride 0.3% and sodium chloride 0.9% | Baxter | Fresenius Kabi |
| 09/18/2020 | Sensipar | cinacalcet HCl | Amgen | Dr Reddys |
| 09/18/2020 | Ponstel | mefenamic acid | Avion | Strides |
| 09/18/2020 | Claritin RediTabs | loratadine | Bayer | Tenshi |
| 09/21/2020 | butalbital / acetaminophen / caffeine | butalbital / acetaminophen / caffeine | Vintage | Strides |
| 09/21/2020 | Cetirizine HCl Allergy | cetirizine HCl allergy | Bionpharma | Catalent |
| 09/21/2020 | Emla | lidocaine / prilocaine | Teva | Rhodes Pharms |
| 09/21/2020 | Imitrex | sumatriptan | Glaxo | Perrigo |
| 09/21/2020 | Isopto Carpine | pilocarpine HCl | Novartis | Amneal |
| 09/22/2020 | Naftin | naftifine HCl | Sebela | Genzum |
| 09/22/2020 | Nexium | esomeprazole magnesium | AstraZeneca | Cisen |
| 09/23/2020 | Exalgo | hydromorphone HCl | SpecGx | Ascent Pharms |
| 09/24/2020 | Alaway | Ketotifen Fumarate | Bausch | Bausch |
| 09/24/2020 | Tecfidera | dimethyl fumarate | Biogen | Cipla |
| 09/24/2020 | Tecfidera | dimethyl fumarate | Biogen | Amneal |
| 09/24/2020 | Tecfidera | dimethyl fumarate | Biogen | Alkem Labs |
| 09/24/2020 | Tecfidera | dimethyl fumarate | Biogen | MSN |
| 09/24/2020 | Tecfidera | dimethyl fumarate | Biogen | Accord Healthcare |
| 09/24/2020 | Tecfidera | dimethyl fumarate | Biogen | Hetero Labs |
| 09/24/2020 | Tecfidera | dimethyl fumarate | Biogen | Zydus Pharms |
| 09/24/2020 | Aleve PM | naproxen sodium / diphenhydramine HCl | Bayer | Granules |
| 09/24/2020 | Rubramin PC | cyanocobalamin | Bristol-Myers Squibb | Gland Pharma |
| 09/29/2020 | Tykerb | lapatinib ditosylate | Novartis | Natco Pharma |
| 09/29/2020 | Atropine Sulfate | atropine sulfate | Accord | Accord Healthcare |
| 09/30/2020 | Bromfed DM | brompheniramine maleate / pseudoephedrine HCl / dextromethorphan hydrobromide | Wockhardt | Breckenridge |
| 09/30/2020 | Trandate | labetalol HCl | County Line | Epic Pharma |
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