ANDA Approvals - Fall 2020

Robins Kaplan LLP

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.

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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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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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