ANDA Approvals

Robins Kaplan LLP

Spring 2019

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Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
1/2/2019 Mirapex ER Pramipexole Dihydrochloride Boehringer Ingelheim Alembic Pharms
1/3/2019 Latuda Lurasidone HCl Sunovion Amneal
1/3/2019 Latuda Lurasidone HCl Sunovion Invagen Pharms
1/3/2019 Latuda Lurasidone HCl Sunovion Lupin
1/3/2019 Latuda Lurasidone HCl Sunovion Accord Hlthcare
1/3/2019 Aubagio Teriflunomide Sanofi Aventis Sandoz
1/3/2019 Dolophine Methadone HCl West-Ward Pharms Ascent Pharms
1/4/2019 Naproxen Sodium Naproxen Sodium (OTC) Bionpharma Catalent
1/4/2019 Latuda Lurasidone HCl Sunovion Sun Pharma
1/4/2019 Rythmol SR Propafenone HCl GlaxoSmithKline Sinotherapeutics
1/7/2018 Abilify Aripiprazole Otsuka Zydus
1/7/2018 Zytiga Abiraterone Acetate Janssen Amneal
1/7/2018 Picato Ingenol Mebutate Leo Labs Perrigo UK Finco
1/7/2018 Aubagio Teriflunomide Sanofi Aventis Accord Healthcare
1/8/2019 Exelon Rivastigmine Novartis Amneal
1/8/2019 CellCept Mycophenolate Mofetil Roche Concord Biotech
1/9/2019 Picato Ingenol Mebutate Leo Labs Perrigo
1/9/2019 Medrol Methylprednisolone Pharmacia and Upjohn RiconPharma
1/10/2019 Benicar Olmesartan Medoxomil Daiichi Sankyo Qilu Pharm
1/10/2019 Fluoxetine HCl Fluoxetine HCl Alvogen Sciegen
1/11/2019 Caduet Amlodipine Besylate / Atorvastatin Calcium Pfizer Zydus
1/11/2019 Betamethasone Dipropionate Betamethasone Dipropionate Fougera Zydus
1/11/2019 Zovirax Acyclovir Bausch & Lomb Torrent
1/11/2019 Femara Letrozole Novartis Eugia Pharma
1/14/2019 Viramune Nevirapine Boehringer Ingelheim MacLeods
1/14/2019 Microzide Hydrochlorothiazide Allergan Sales Sciegen
1/14/2019 Busulfex Busulfan Otsuka Nexus Pharms
1/14/2019 Lotronex Alosetron HCl Sebela Rising Pharms
1/14/2019 Sabril Vigabatrin Lundbeck Teva
1/15/2019 Relpax Eletriptan Hydrobromide Pfizer Aurobindo
1/15/2019 Plaquenil Hydroxychloroquine Sulfate Concordia Pharms Laurus Labs
1/16/2019 Diamox Acetazolamide Teva Xylopia
1/16/2019 Effient Prasugrel Eli Lilly and Co HEC Pharm
1/16/2019 Syprine Trientine HCl Aton Navinta
1/17/2019 Gleevec Imatinib Mesylate Novartis Shilpa Medicare
1/17/2019 Gleevec Imatinib Mesylate Novartis Wockhardt
1/18/2019 Precedex Dexmedetomidine HCl Hospira Cipla
1/18/2019 Prevacid Lansoprazole Takeda Alkem Labs
1/18/2019 Levo-T / Synthroid / Thyro-Tabs/ Unithroid Levothyroxine Sodium Cediprof / AbbVie / Lloyd / Stevens Lupin
1/18/2019 Cyclophosphamide Cyclophosphamide West-Ward Pharms Cipla
1/18/2019 Zovirax Acyclovir Bausch & Lomb Cipla
1/22/2019 Adderall XR Dextroamp Saccharate / AMP Aspartate / Dextroamp Sulfate / AMP Sulfate Shire Amerigen Pharms
1/22/2019 Klor-Con Potassium Chloride Upsher-Smith Labs PII
1/22/2019 Tikosyn Dofetilde Pfizer Aurobindo
1/22/2019 Retin-A Tretinoin Valeant  Taro Pharms
1/23/2019 Brilinta Ticagrelor AstraZeneca Amneal
1/23/2019 Brilinta Ticagrelor AstraZeneca Hisun Pharm Hangzhou
1/24/2019 Trusopt Dorzolamide HCl Merck FDC
1/24/2019 Suboxone Buprenorphine HCl / Naloxone HCl Indivior Alvogen Pine Brook
1/25/2019 Aleve PM Naproxen Sodium / Diphenhydramine Chloride Bayer Healthcare Actavis
1/25/2019 Integrilin Eptifibatide Schering Hainan Poly Pharm
1/25/2019 Bentyl Dicyclomine HCl Allergan Fresenius Kabi
1/25/2019 Depo-Provera Medroxyprogesterone  Acetate Pharmacia and Upjohn Cipla
1/25/2019 Retin-A Tretinoin Valeant Taro Pharms
1/25/2019 Fluoxetine Hydrochloride Fluoxetine Hydrochloride Alvogen Dr Reddy's Labs
1/25/2019 Zanaflex Tizanidine HCl Covis Pharma Alkem Labs
1/25/2019 Lialda Mesalamine Shire Sun Pharm
1/28/2019 Lactated Ringer's in Plastic Container Sodium Chloride / Sodium Lactate / Potssium Chloride / Calcium Chloride in Water Baxter Healthcare Fresenius Kabi
1/28/2019 Cleocin T Clindamycin Phosphate Pharmacia and Upjohn Encube Ethicals
1/28/2019 DDAVP Desmopressin Acetate Ferring Pharms Abhai
1/28/2019 Wellbutrin XL Bupropion HCl Valeant Graviti Pharms
1/28/2019 Rapamune Sirolimus PF Prism Novitium Pharma
1/29/2019 Vazculep Phenylephrine HCl West-Ward Pharm / Avadel Legacy Fresenius Kabi
1/30/2019 Advair Wixela Inhub Glaxo  Mylan
1/30/2019 Vazculep Phenylephrine HCl Avadel Legacy Fresenius Kabi
1/30/2019 Desonide Desonide Perrigo Encube Ethicals
1/30/2019 Onfi Clobazam Lundbeck Micro Labs
1/31/2019 Vazculep Phenylephrine HCl West-Ward Pharm / Avadel Legacy Sandoz
1/31/2019 Protopic Tacrolimus Leo Pharma Accord Healthcare
2/1/2019 Bentyl Dicyclomine HCl Allergan Nexus Pharms
2/1/2019 Ritalin Methylphenidate HCl Novartis Cediprof
2/4/2019 Trandate Labetalol HCl County Line Pharms Invatech Pharma
2/4/2019 Zovirax Acyclovir Bausch & Lomb Perrigo
2/4/2019 Fetzima Levomilnacipran HCl Allergan Amneal
2/4/2019 Oxycodone HCl Oxycodone HCl Genus Lifesciences Alkem Labs
2/5/2019 Adcirca Tadalafil Eli Lilly and Co Aurobindo
2/5/2019 Adcirca Tadalafil Eli Lilly and Co Hetero
2/5/2019 Adcirca Alyq Eli Lilly and Co Teva
2/5/2019 Adcirca Tadalafil Eli Lilly and Co Dr Reddy's Labs
2/5/2019 Adcirca Tadalafil Eli Lilly and Co Cipla
2/5/2019 Adcirca Tadalafil Eli Lilly and Co Ajanta Pharma
2/5/2019 Adcirca Tadalafil Eli Lilly and Co Lupin
2/5/2019 Vivelle-Dot Estradiol Novartis Amneal
2/6/2019 Seasonale Sylevia Teva  Sun Pharm
2/7/2019 Tegretol-XR Carbamazepine Novartis Zydus
2/7/2019 Nicorette Nicotine Polacrilex GlaxoSmithKline PLD Acquisitions
2/7/2019 Benicar HCT Olmesartan Medoxomil / Hydrochlorothiazide Daiichi Sankyo Accord Healthcare
2/7/2019 Oxycodone HCl Oxycodone HCl Genus Lifesciences / VistaPharm Alkem Labs
2/8/2019 Renagel Sevelamer HCl Genzyme Glenmark
2/8/2019 Gleevec Imatinib Mesylate Novartis Breckenridge
2/8/2019 Gleevec Imatinib Mesylate Novartis Amneal
2/8/2019 Ferriprox Deferiprone Apopharma Taro Pharm
2/8/2019 Syprine Trientine HCl Aton Amneal
2/8/2019 Colcrys Colchicine Takeda Alkem Labs
2/8/2019 Fluoxetine HCl Fluoxetine HCl Alvogen Lupin
2/8/2019 Lipitor Atorvastatin Calcium Pfizer MSN Labs
2/11/2019 Dyazide Triamterene and Hydrochlorothiazide GlaxoSmithKline Zydus
2/11/2019 Omeprazole Omeprazole (OTC) Dexcel Pharma Apotex
2/11/2019 Triamcinolone Acetonide Triamcinolone Acetonide Mylan Strides Pharma
2/11/2019 Bentyl Dicyclomine HCl Allergan Custopharm
2/12/2019 CellCept Mycophenolate Mofetil Roche VistaPharm
2/13/2019 Vigamox Moxifloxacin HCl Novartis  Alembic Pharms
2/13/2019 Synalar Fluocinolone Acetonide Medimetriks Pharms Encube Ethicals
2/14/2019 DDAVP Desmopressin Acetate Ferring Luitpold
2/14/2019 Gemcitabine HCl Gemcitabine HCl Hospira Ingenus Pharms
2/14/2019 Advil PM Ibuprofen / Diphenhydramine HCl Pfizer Aurobindo Pharma
2/15/2019 Eloxatin Oxaliplatin Sanofi Aventis  / Teva Sun Pharma
2/15/2019 Actonel Risedronate Sodium Apil Hangzhou Binjiang
2/15/2019 Olux Clobetasol Propionate Mylan Glenmark
2/19/2019 Micardis Telmisartan Boehringer Ingelheim Hisun Pharm Hangzhou
2/19/2019 Diamox Acetazolamide Teva  Alembic Pharms
2/19/2019 Levo-T / Levoxyl / Synthroid / Unithroid Levothyroxine Sodium Cediprof / King Pharms / AbbVie / Stevens Amneal
2/19/2019 Marcaine Bupivacaine HCl Hospira Novocol Healthcare
2/19/2019 Colcrys Colchicine Takeda Zydus
2/19/2019 Zarontin Ethosuximide Parke Davis Strides
2/20/2019 Zovirax Acyclovir Bausch & Lomb Perrigo
2/20/2019 Nimbex Cisatracurium Besylate Preservative Free AbbVie Somerset Theraps
2/20/2019 Mephyton Phytonadione Bausch & Lomb Zydus
2/21/2019 Rocaltrol Calcitriol Validus Pharms Sun Pharm
2/21/2019 Abilify Aripiprazole Otsuka Alkem Labs
2/21/2019 Aromasin Exemestane Pharmacia and Upjohn Breckenridge
2/22/2019 Niaspan Niacin AbbVie Mylan
2/22/2019 Antivert Meclizine HCl Casper Pharma Indicus Pharma
2/22/2019 Gemzar Gemcitabine HCl Eli Lilly and Co Shilpa Medicare
2/22/2019 Medrol Methylprednisolone Pharmacia and Upjohn Lupin
2/22/2019 Cyklokapron Tranexamic Acid Pharmacia and Upjohn Acic Pharms
2/22/2019 Busulfex Busulfan Otsuka Accord Healthcare
2/22/2019 Benicar Olmesartan Medoxomil Daiichi Sankyo Sunshine Lake
2/22/2019 Tessalon Benzonatate Pfizer Ascent Pharms
2/22/2019 Clolar Clofarabine Genzyme Accord Healthcare
2/25/2019 Flagyl I.V. RTU in Plastic Container / Metro I.V. in Plastic Container / Metronidazole in Plastic Container Metronidazole in Plastic Container Baxter Healthcare / B Braun / Hospira Inforlife
2/25/2019 Lovaza Omega-3-Acid Ethyl Esters SmithKline Beecham Ascent Pharms
2/25/2019 Zytiga Abiraterone Acetate Janssen Rising Pharms
2/26/2019 Zithromax Azithromycin Pfizer Bionpharma
2/26/2019 Zithromax Azithromycin Pfizer Bionpharma
2/27/2019 Zytiga Abiraterone Acetate Janssen Wockhardt
2/27/2019 Vidaza Azacitidine Celgene Lupin
2/27/2019 Tamiflu Oseltamivir Phosphate Roche Teva
2/28/2019 Ditropan XL Oxybutynin Chloride Janssen Ajanta
3/1/2019 Perphenazine Perphenazine Sandoz Rising Pharms
3/1/2019 Crestor Rosuvastatin Calcium IPR Zydus
3/1/2019 Gleevec Imatinib Mesylate Novartis Natco Pharma
3/1/2019 Protonix Pantoprazole Sodium Wyeth Ingenus Pharms
3/4/2019 Micardis HCT Telmisartan / Hydrochlorothiazide Boehringer Ingelheim Glenmark
3/4/2019 Exelon Rivastigmine Novartis Zydus
3/4/2019 Faslodex Fulvestrant AstraZeneca Amneal
3/5/2019 Epivir Lamivudine ViiV Healthcare Mylan
3/5/2019 Bepreve Bepotastine Besilate Bausch and Lomb Apotex
3/5/2019 Nexium 24Hr Esomeprazole Magnesium AstraZeneca Actavis
3/5/2019 Kapvay Clonidine HCl Concordia Pharms Novast Labs
3/6/2019 Lipitor Atorvastatin Calcium Pfizer Lupin
3/8/2019 Tenoretic Atenolol and Chlorthalidone Alvogen Malta Zydus
3/8/2019 Mestinon Pyridostigmine Bromide Bausch Novitium Pharma
3/11/2019 Integrilin Eptifibatide Schering USV
3/11/2019 Micro-K / Micro-K 10 Potassium Chloride Nesher Pharms Zydus
3/11/2019 Ampyra Dalfampridine Acorda Micro Labs
3/12/2019 Diovan Valsartan Novartis Alkem
3/12/2019 Claritin Loratadine Bayer Healthcare Newgen Pharms
3/12/2019 Zanaflex Tizanidine HCl Covis Pharma RiconPharma
3/12/2019 Procardia XL Nifedipine Pfizer Novast Labs
3/12/2019 Zyloprim Allopurinol Casper Pharma Unichem Labs
3/12/2019 Desonide Desonide Perrigo Teligent Pharma
3/13/2019 Yasmin Kemeya Bayer Healthcare Sun Pharm
3/13/2019 Sodium Chloride 3% in Plastic Container Sodium Chloride 3% in Plastic Container Baxter Healthcare Fresenius Kabi
3/13/2019 Children's Zyrtec  Cetirizine HCl J and J Consumer Hetero Labs Ltd III
3/14/2019 Integrilin Epifibatide Schering USV
3/14/2019 Lovenox Enoxaparin Sodium Sanofi Aventis Amphastar
3/15/2019 Diovan HCT Valsartan / Hydrochlorothiazide Novartis Zydus
3/15/2019 Zovirax Acyclovir Bausch Zydua
3/18/2019 Bepreve Bepotastine Besilate Bausch and Lomb Micro Labs
3/18/2019 Lidex Fluocinonide County Line Pharms Teligent Pharma
3/19/2019 Invanz Ertapenem Sodium Merck Sharp Dohme Savior Lifetec
3/19/2019 Latuda Lurasidone HCl Sunovion Zydus
3/20/2019 Aggrenox Aspirin / Dipyridamole Boehringer Ingelheim Lannett
3/20/2019 Naftin Naftifine HCl Sebela Tolmar
3/21/2019 Epivir-HBV Lamivudine GlaxoSmithKline Annora
3/22/2019 Tekturna Aliskiren Hemifumarate Noden Pharma Anchen Pharms
3/22/2019 Daliresp Roflumilast AstraZeneca Micro Labs
3/22/2019 Makena Preservative Free Hydroxyprogesterone Caproate Amag Pharma Slayback Pharma
3/22/2019 Yaz Drospirenone / Ethinyl Estradiol Bayer Healthcare Hetero
3/22/2019 Viagra Sildenafil Citrate Pfizer Lupin
3/25/2019 Viagra Sildenafil Citrate Pfizer Mylan
3/25/2019 Nuvigil Armodafinil Cephalon Apotex
3/26/2019 Baraclude Entecavir Bristol-Myers Squibb Mylan
3/26/2019 Cialis Tadalafil Eli Lilly and Co Alembic
3/26/2019 Cialis Tadalafil Eli Lilly and Co Aurobindo
3/26/2019 Cialis Tadalafil Eli Lilly and Co Zydus
3/26/2019 Cialis Tadalafil Eli Lilly and Co Sun Pharm
3/26/2019 Cialis Tadalafil Eli Lilly and Co Accord Healthcare
3/26/2019 Cialis Tadalafil Eli Lilly and Co Unichem Labs
3/26/2019 Cialis Tadalafil Eli Lilly and Co Cipla 
3/26/2019 Cialis Tadalafil Eli Lilly and Co Ajanta
3/26/2019 Cialis Tadalafil Eli Lilly and Co Amneal
3/26/2019 Cialis Tadalafil Eli Lilly and Co Hetero
3/26/2019 Cialis Tadalafil Eli Lilly and Co Dr Reddy's Labs
3/26/2019 Cialis Tadalafil Eli Lilly and Co Qilu Pharm
3/26/2019 Cialis Tadalafil Eli Lilly and Co Lupin
3/26/2019 Cialis Tadalafil Eli Lilly and Co Sunshine Lake
3/26/2019 Cialis Tadalafil Eli Lilly and Co Torrent
3/26/2019 Adcirca Tadalafil Eli Lilly and Co Torrent
3/26/2019 Zanaflex Tizanidine HCl Covis Pharma Cadila
3/27/2019 Zanaflex Tizanidine HCl Covis Pharma Alkem Labs
3/28/2019 Letairis Ambrisentan Gilead Watson
3/28/2019 Letairis Ambrisentan Gilead Mylan
3/28/2019 Letairis Ambrisentan Gilead Zydus
3/28/2019 Letairis Ambrisentan Gilead Sun Pharm
3/28/2019 Xyzal Allergy 24Hr Levocetirizine Dihydrochloride Sanofi Avenits Perrigo
3/29/2019 Cialis Tadalafil Eli Lilly and Co Watson
3/29/2019 Azilect Rasagiline Mesylate Teva Micro Labs
3/29/2019 Potassium Chloride Potassium Chloride Genus Lifesciences Pharm Assoc
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As with many websites, JD Supra's website (located at www.jdsupra.com) (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

  1. Improve the user experience on our Website and Services;
  2. Store the authorization token that users receive when they login to the private areas of our Website. This token is specific to a user's login session and requires a valid username and password to obtain. It is required to access the user's profile information, subscriptions, and analytics;
  3. Track anonymous site usage; and
  4. Permit connectivity with social media networks to permit content sharing.

There are different types of cookies and other technologies used our Website, notably:

  • "Session cookies" - These cookies only last as long as your online session, and disappear from your computer or device when you close your browser (like Internet Explorer, Google Chrome or Safari).
  • "Persistent cookies" - These cookies stay on your computer or device after your browser has been closed and last for a time specified in the cookie. We use persistent cookies when we need to know who you are for more than one browsing session. For example, we use them to remember your preferences for the next time you visit.
  • "Web Beacons/Pixels" - Some of our web pages and emails may also contain small electronic images known as web beacons, clear GIFs or single-pixel GIFs. These images are placed on a web page or email and typically work in conjunction with cookies to collect data. We use these images to identify our users and user behavior, such as counting the number of users who have visited a web page or acted upon one of our email digests.

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

  • HubSpot - For more information about HubSpot cookies, please visit legal.hubspot.com/privacy-policy.
  • New Relic - For more information on New Relic cookies, please visit www.newrelic.com/privacy.
  • Google Analytics - For more information on Google Analytics cookies, visit www.google.com/policies. To opt-out of being tracked by Google Analytics across all websites visit http://tools.google.com/dlpage/gaoptout. This will allow you to download and install a Google Analytics cookie-free web browser.

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit http://www.aboutcookies.org which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.