- Acumen Powered by Robins Kaplan LLP®
- Affirmative Recovery
- American Indian Law and Policy
- Antitrust and Trade Regulation
- Appellate Advocacy and Guidance
- Business Litigation
- Civil Rights and Police Misconduct
- Class Action Litigation
- Commercial/Project Finance and Real Estate
- Corporate Governance and Special Situations
- Corporate Restructuring and Bankruptcy
- Domestic and International Arbitration
- Health Care Litigation
- Insurance and Catastrophic Loss
- Intellectual Property and Technology Litigation
- Mass Tort Attorneys
- Medical Malpractice Attorneys
- Personal Injury Attorneys
- Telecommunications Litigation and Arbitration
- Wealth Planning, Administration, and Disputes
Acumen Powered by Robins Kaplan LLP®
Ediscovery, Applied Science and Economics, and Litigation Support Solutions
-
June 1, 2022Chambers USA Recognizes Five Robins Kaplan Practice Groups And 17 Lawyers In 2022 Guide
-
June 1, 2022Seasoned Attorney Joins Firm’s Business Litigation Group
-
May 26, 2022Shira Shapiro Named Woman of Promise By The Pearl Society
-
June 3, 202219th Annual Advanced Insurance Law
-
June 9, 2022Building Your Brand: Perspectives and Insights from a Diverse Bar
-
June 10, 2022LGBTQ Legal Services: Transgender Name Change Clinic
-
May 24, 2022Briefly: Seeking Fees and Costs While on Appeal
-
May 19, 202211th Circ. Ban On Service Awards May Inhibit Class Actions
-
May 13, 2022Trademark Applications and the Murky Waters of Subject Matter Jurisdiction
-
June 2, 2022Sandberg Stepping Down as Meta COO After 14 Years
-
June 1, 2022Markets Revert to Recent Form as Pessimism Takes Hold
-
May 27, 2022Unexpectedly Strong Retail Sales Pull Markets Back from the Brink
Find additional firm contact information for press inquiries.
Find resources to help navigate legal and business complexities.
Read our attorneys' take on the latest news and trends in the legal and business industries.
ANDA Approvals
New Drug Applications and 505(b)(2) Applications
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 |
---|---|---|---|---|
01/03/2022 | Esbriet | Pirfenidone | Genentech | Amneal |
01/03/2022 | Doryx | Doxycycline Hyclate | Mayne | Alembic Pharms |
01/03/2022 | Rapaflo | Silodosin | AbbVie | Upsher Smith |
01/04/2022 | Vesicare | Solifenacin Succinate | Astellas | Accord Healthcare |
01/04/2022 | Rapaflo | Silodosin | AbbVie | Prinston |
01/04/2022 | Toprol XL | Metoprolol Succinate | AstraZeneca | Prinston |
01/04/2022 | Comtan | Entacapone | Orion | Alembic Pharms |
01/04/2022 | Migranal | Dihydroergotamine Mesylate | Bausch | Amneal |
01/04/2022 | Effexor ER | Venlafaxine HCl | Wyeth | Pharmadax |
01/05/2022 | Tamiflu | Oseltamivir Phosphate | Roche | Sunshine |
01/05/2022 | Progesterone | Progesterone | Actavis | Xiromed |
01/05/2022 | Zytiga | Abiraterone Acetate | Johnson & Johnson | Oncogen Pharma |
01/06/2022 | Colcrys | Colchicine | Takeda | Aurobindo |
01/07/2022 | Pepcid | Famotidine | Bausch | VKT |
01/10/2022 | Transderm Scop | Scopolamine | Baxter Healthcare | Actavis Labs |
01/11/2022 | Trileptal | Oxcarbazepine | Novartis | Annora Pharma |
01/12/2022 | Morphine Sulfate | Morphine Sulfate | Hikma | Mayne Pharma |
01/13/2022 | Tamiflu | Oseltamivir Phosphate | Roche | Strides |
01/13/2022 | Potassium Chloride | Potassium Chloride | Genus | Rubicon |
01/14/2022 | Differin | Adapalene | Galderma | Taro Pharms |
01/18/2022 | Amitiza | Lubiprostone | Sucampo | Teva |
01/18/2022 | Cleocin T | Clindamycin Phosphate | Pfizer | Encube |
01/19/2022 | Kenalog 40 | Triamcinolone Acetonide | Apothecon | Custopharm / Long Grove Pharms |
01/19/2022 | Ranexa | Ranolazine | Gilead | VKT Pharma |
01/19/2022 | Floxin Otic | Ofloxacin | Daiichi Sankyo | FDC |
01/19/2022 | Sabril | Vigabatrin | Lundbeck | Zydus |
01/20/2022 | Esbriet | Pirfenidone | Genentech | Accord Healthcare |
01/21/2022 | Welchol | Colesevelam HCl | Daiichi Sankyo | SPH |
01/21/2022 | Depo Medrol | Methylprednisolone Acetate | Pfizer | Par |
01/21/2022 | Questran | Cholestyramine | Bristol-Myers Squib | Upsher Smith |
01/24/2022 | Atripla | Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate | Gilead | Hetero Labs |
01/24/2022 | Fosrenol | Lanthanum Carbonate | Takeda | Invagen Pharms |
01/24/2022 | Hectorol | Doxercalciferol | Genzyme | Aurobindo / Eugia Pharma |
01/25/2022 | Hygroton | Chlorthalidone | Sanofi Aventis | Sunny |
01/25/2022 | Cellcept | Mycophenolate Mofetil | Roche | Teva |
01/25/2022 | Esbriet | Pirfenidone | Genentech | Accord Healthcare |
01/25/2022 | Esbriet | Pirfenidone | Genentech | Teva |
01/25/2022 | Stalevo | Carbidopa / Levodopa / Entacapone | Orion | Rising |
01/25/2022 | Lioresal | Baclofen | Novartis | Mankind Pharma |
01/25/2022 | Cosopt | Dorzolamide HCl / Timolol Maleate | Akorn | Micro Labs |
01/26/2022 | Pomalyst | Pomalidomide | Celgene | Mylan |
01/26/2022 | Monurol | Fosfomycin Tromethamine | AbbVie | Cipla |
01/26/2022 | Aloprim | Allopurinol | Mylan | Gland Pharma |
01/26/2022 | Potassium Chloride | Potassium Chloride | Genus | Tris Pharma |
01/26/2022 | Fioricet with codeine | Butalbital / Acetaminophen / Caffeine / Codeine Phosphate | Teva | Hikma |
01/26/2022 | Atropine sulfate | Atropine Sulfate | Hospira | Amneal |
01/26/2022 | Ziac | Bisoprolol Fumarate / Hydrochlorothiazide | Teva | Glenmark |
01/27/2022 | Fosrenol | Lanthanum Carbonate | Takeda | Barr |
01/27/2022 | Sovaldi | Sofosbuvir | Gilead | Teva |
01/27/2022 | Lasix | Furosemide | Sanofi Aventis | Hong Kong |
01/27/2022 | Klor-con | Potassium Chloride | Upsher-Smith | Granules |
01/27/2022 | Chlorpromazine HCl | Chlorpromazine HCl | Upsher-Smith | MSN Labs |
01/27/2022 | Hemabate | Carboprost Tromethamine | Pfizer | Amneal |
01/27/2022 | Trusopt | Dorzolamide HCl | Merck | Gland Pharma |
01/27/2022 | Metrogel-Vaginal | Metronidazole | Bausch | Glenmark |
01/28/2022 | Zioptan | Tafluprost | Akorn | Sandoz |
01/28/2022 | Cystadane | Betaine | Recordati | Lukare Medical |
01/28/2022 | Pepcid AC | Famotidine | Johnson & Johnson | Vkt Pharma |
01/31/2022 | Qoliana / Alphagan P | Brimonidine Tartrate | Sandoz / Allergan | Apotex |
01/31/2022 | Biaxin | Clarithromycin | AbbVie | Alembic Pharms |
01/31/2022 | Adderall XR | Dextroamp Saccharate / Amp Aspartate / Dextroamp Sulfate / Amp Sulfate | Takeda | Teva |
02/01/2022 | Mucinex D | Guaifenesin / Pseudoephedrine HCl | Reckitt | Padagis |
02/02/2022 | Restasis | Cyclosporine | AbbVie | Mylan |
02/02/2022 | Excedrin Migraine | Acetaminophen / Aspirin / Caffeine | Glaxo | Aurobindo |
02/02/2022 | Limbitrol | Chlordiazepoxide / Amitriptyline HCl | Heritage | Micro Labs |
02/02/2022 | Reyataz | Atazanavir Sulfate | Bristol-Myers Squib | Hetero Labs |
02/02/2022 | Wellbutrin XL | Bupropion HCl | Bausch | Granules |
02/03/2022 | Zavesca | Miglustat | Actelion | Breckenridge |
02/03/2022 | Vidaza | Azacitidine | Celgene | Amneal |
02/03/2022 | Mirapex ER | Pramipexole Dihydrochloride | Boehringer Ingelheim | Novast Labs |
02/03/2022 | Acetadote | Acetylcysteine | Cumberland | Aspen |
02/03/2022 | Lamictal ODT | Lamotrigine | Glaxo | Amring Pharms |
02/04/2022 | Aczone 7.5% gel | Dapsone | Almirall | Mylan |
02/04/2022 | Noxafil | Posaconazole | Merck | Biocon Pharma |
02/07/2022 | Selzentry | Maraviroc | ViiV | Hetero Labs |
02/07/2022 | Brovana | Arformoterol Tartrate | Mylan | Lupin |
02/07/2022 | Renvela | Sevelamer Carbonate | Sanofi | Micro Labs |
02/07/2022 | Morphine Sulfate | Morphine Sulfate | Hikma | Riconpharma |
02/07/2022 | Anectine / Quelicin | Succinylcholine Chloride | Sandoz / Hospira | Be Pharms |
02/08/2022 | Amitiza | Lubiprostone | Sucampo | Dr Reddys Labs |
02/08/2022 | Revex | Nalmefene HCl | Eurohealth | Purdue Pharma |
02/08/2022 | Bactrim | Sulfamethoxazole / Trimethoprim | Sun Pharma | Novitium Pharma |
02/08/2022 | Revatio | Sildenafil Citrate | Viatris | MSN Labs |
02/08/2022 | Lanoxin | Digoxin | Advanz | Aurobindo |
02/09/2022 | Chlorthalidone | Chlorthalidone | Mylan | Inventia |
02/09/2022 | Sinequan | Doxepin HCl | Pfizer | Mankind Pharma |
02/10/2022 | Daliresp | Roflumilast | AstraZeneca | Zydus |
02/10/2022 | Veltin gel | Clindamycin Phosphate / Tretinoin | Almirall | Solaris Pharma |
02/10/2022 | Faslodex | Fulvestrant | AstraZeneca | Jiangsu Hansoh Pharm |
02/10/2022 | Aczone 7.5% gel | Dapsone | Almirall | Torrent |
02/10/2022 | Nexium IV | Esomeprazole Sodium | AstraZeneca | Hainan Poly |
02/11/2022 | Tobradex | Tobramycin / Dexamethasone | Novartis | Padagis |
02/14/2022 | Erythrocin | Erythromycin Lactobionate | Hospira | Nexus Pharms |
02/15/2022 | Samsca | Tolvaptan | Otsuka | Par |
02/15/2022 | Vancomycin HCl | Vancomycin HCl | Baxter | Knack |
02/16/2022 | Sanctura | Trospium Chloride | Allergan | Amici |
02/17/2022 | Antivert | Meclizine HCl | Casper | Cipla |
02/17/2022 | Valcyte | Valganciclovir HCl | Roche | Airis Pharma |
02/17/2022 | Embeline | Clobetasol Propionate | Akorn | Solaris Pharma |
02/18/2022 | Macrobid | Nitrofurantoin Monohydrate / Macrocrystals | Almatica | Inventia |
02/18/2022 | Symmetrel | Amantadine HCl | Endo | Strides |
02/18/2022 | Lyrica | Pregabalin | Pfizer | Invatech |
02/18/2022 | Cardioplegic / Plegisol | Cardioplegic / Plegisol | Hospira | Fresenius Kabi USA |
02/18/2022 | Betamethasone Dipropionate | Betamethasone Dipropionate | Fougera Pharms | Tasman Pharma |
02/18/2022 | Testred | Methyltestosterone | Bausch | Novitium Pharma |
02/22/2022 | Farxiga | Dapagliflozin | AstraZeneca | Zydus |
02/22/2022 | Fortamet | Metformin HCl | Teva | Sciegen Pharms |
02/23/2022 | Apokyn | Apomorphine HCl | Supernus | Sage Chems |
02/23/2022 | Jadenu Sprinkle | Deferasirox | Novartis | Cipla |
02/23/2022 | Acetadote | Acetylcysteine | Cumberland | Indoco |
02/23/2022 | Maxzide | Triamterene / Hydrochlorothiazide | Mylan | Rubicon |
02/24/2022 | Chlorthalidone | Chlorthalidone | Mylan | Tagi |
02/24/2022 | Epaned | Enalapril Maleate | Azurity | Annora Pharma |
02/25/2022 | Depakote ER | Divalproex Sodium | AbbVie | Unichem |
02/25/2022 | Akovaz | Ephedrine Sulfate | Exela | Gland Pharma |
02/28/2022 | Cytarabine | Cytarabine | Teva | Hong Kong |
02/28/2022 | Tamiflu | Oseltamivir Phosphate | Roche | Leading Pharma |
02/28/2022 | Navane | Thiothixene | Pfizer | Amneal |
03/01/2022 | Bonjesta | Doxylamine Succinate / Pyridoxine HCl | Duchesnay | Actavis Labs |
03/02/2022 | Jublia | Efinaconazole | Bausch | Lupin |
03/02/2022 | Brovana | Arformoterol Tartrate | Mylan | Vistapharm |
03/03/2022 | Niaspan | Niacin | AbbVie | Macleods |
03/04/2022 | Mykacet | Nystatin / Triamcinolone Acetonide | Cosette | Aleor Dermaceuticals |
03/04/2022 | Cambia | Diclofenac Potassium | Assertio | Annora Pharma |
03/07/2022 | Zyloprim | Allopurinol | Casper | Harman Finochem |
03/08/2022 | Nitrostat | Nitroglycerin | Viatris | Zydus |
03/08/2022 | Lyrica | Pregabalin | Pfizer | Eskayef |
03/10/2022 | Colcrys | Colchicine | Takeda | Strides |
03/10/2022 | Sabril | Vigabatrin | Lundbeck | Lupin |
03/10/2022 | Nilstat | Nystatin | Glenmark | Medley |
03/10/2022 | Colestid | Colestipol HCl | Pfizer | Zydus |
03/11/2022 | Nimbex | Cisatracurium Besylate | AbbVie | Piramal Healthcare |
03/11/2022 | Digoxin | Digoxin | Hikma | Amici |
03/14/2022 | Daytrana | Methylphenidate | Noven | Mylan |
03/14/2022 | Sinequan | Doxepin HCl | Pfizer | Jubilant Cadista |
03/15/2022 | Breyna | Budesonide / Formoterol Fumarate Dihydrate | AstraZeneca | Mylan |
03/15/2022 | Carafate | Sucralfate | AbbVie | Vistapharm |
03/15/2022 | Cardura | Doxazosin Mesylate | Viatris | Method |
03/15/2022 | Bystolic | Nebivolol HCl | AbbVie | Unichem |
03/15/2022 | Mucinex | Guaifenesin | Reckitt Benckiser | Dr Reddys Labs |
03/17/2022 | Vimpat | Lacosamide | UCB | Hetero Labs |
03/17/2022 | Vimpat | Lacosamide | UCB | Amneal |
03/17/2022 | Vimpat | Lacosamide | UCB | MSM Labs |
03/17/2022 | Vimpat | Lacosamide | UCB | Alembic |
03/17/2022 | Vimpat | Lacosamide | UCB | Glenmark |
03/17/2022 | Vimpat | Lacosamide | UCB | Sun Pharm |
03/17/2022 | Vimpat | Lacosamide | UCB | Sciegen Pharms |
03/17/2022 | Pentam | Pentamidine Isethionate | Fresenius Kabi | Xgen Pharms |
03/17/2022 | Vimpat | Lacosamide | UCB | Indoco |
03/17/2022 | Isoptin | Verapamil HCl | Mt Adams Technologies | Acic Pharms |
03/18/2022 | Xibrom | Bromfenac Sodium | Bausch | Eugia Pharma |
03/21/2022 | Sklice | Ivermectin | Arbor | Teva |
03/21/2022 | Kaletra | Lopinavir / Ritonavir | AbbVie | Laurus |
03/21/2022 | Brevibloc | Esmolol HCl | Baxter | Eugia Pharma |
03/22/2022 | Lyrica CR | Pregabalin | Pfizer | Rubicon |
03/23/2022 | Revatio | Sildenafil Citrate | Viatris | Lupin |
03/23/2022 | Inspra | Eplerenone | Pfizer | Kartha |
03/23/2022 | Amicar | Aminocaproic Acid | Akorn | Agenix |
03/23/2022 | Toradol | Ketorolac Tromethamine | Roche | Havix (Senores) |
03/23/2022 | Laying-O-Jet Kit | Lidocaine HCl | Amphastar | Novitium Pharma |
03/24/2022 | Klor-con | Potassium Chloride | Upsher-Smith | Rubicon |
03/24/2022 | Onfi | Clobazam | Lundbeck | Aurobindo |
03/25/2022 | Esbriet | Pirfenidone | Genentech | Amneal |
03/25/2022 | Butalbital / Acetaminophen / Caffeine | Butalbital / Acetaminophen / Caffeine | Gilbert | Hikma |
03/28/2022 | Uloric | Febuxostat | Takeda | Prinston |
03/28/2022 | Keppra | Levetiracetam | UCB | Prinston |
03/28/2022 | Tamiflu | Oseltamivir Phosphate | Roche | Hetero Labs |
03/28/2022 | Dextrose 5% and Lactated Ringer's | Dextrose 5% and Lactated Ringer's | ICU Medical | Fresenius Kabi USA |
03/28/2022 | Prednisone | Prednisone | Hikma | Aurobindo |
03/29/2022 | Procardia XL | Nifedipine | Pfizer | Alkem Labs |
03/29/2022 | Prozac | Fluoxetine HCl | Eli Lilly | Micro Labs |
03/30/2022 | Sodium Phosphates | Sodium Phosphates | Hospira | Fresenius Kabi USA |
03/30/2022 | Lymepak | Doxycycline Hyclate | Chartwell | Praxgen |
03/30/2022 | Epaned O.S. | Enalapril Maleate | Azurity | Alkem Labs |
03/30/2022 | Datscan | Ioflupane I-123 | GE Healthcare | Curium |
03/30/2022 | Motrin | Ibuprofen | McNeil | Yichang Humanwell |
03/31/2022 | Aczone | Dapsone | AbbVie | SeegPharm |
03/31/2022 | Bystolic | Nebivolol HCl | AbbVie | Ajanta |
03/31/2022 | Vimpat | Lacosamide | UCB | Alkem Labs |
03/31/2022 | Tegretol XR | Carbamazepine | Novartis | Zhejiang Jiuzhou |
03/31/2022 | Zovirax | Acyclovir | Mylan | Aurobindo |
GENERICally Speaking Hatch Waxman Bulletin
Related Professionals
GENERICally Speaking Hatch Waxman Bulletin
READ MORE Related Publications
First Quarter
ANDA Litigation Settlements
GENERICally Speaking Hatch Waxman Bulletin
First Quarter
New ANDA Cases
GENERICally Speaking Hatch Waxman Bulletin
First Quarter
Generic Launches
GENERICally Speaking Hatch Waxman Bulletin
March 22, 2022
Genentech, Inc. v. Sandoz, Inc.
GENERICally Speaking Hatch Waxman Bulletin
Fed. Cir. 2022
GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.
GENERICally Speaking Hatch Waxman Bulletin
Related News
August 2, 2021
Back to Top
Any information that you send us in an e-mail message should not be confidential or otherwise privileged information. Sending us an e-mail message will not make you a client of Robins Kaplan LLP. We do not accept representation until we have had an opportunity to evaluate your matter, including but not limited to an ethical evaluation of whether we are in a conflict position to represent you. Accordingly, the information you provide to us in an e-mail should not be information for which you would have an expectation of confidentiality.
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.