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ANDA Approvals
Summer 2019
![GENERICally Speaking: A Hatch Waxman Litigation Bulletin](/-/media/images/newsletters/generically-speaking-social-graphics/generically-speaking-nwsltr-badge.jpg?la=en&h=160&w=390&la=en&hash=314B8432ED62E0647D7FC4565EC18B79)
Approval Date | Reference Listed Drug | Generic Drug Name | NDA Holder | ANDA Applicant |
---|---|---|---|---|
3/20/2019 | Optivar | azelastine 0.05% solution | Mylan | Alembic |
3/26/2019 | Xyzal Allergy 24HR | levocetrizine | UCB | Perrigo |
3/28/2019 | Letairis | ambrisentan | Gilead | Teva |
3/28/2019 | Letairis | ambrisentan | Gilead | Mylan |
3/28/2019 | Letairis | ambrisentan | Gilead | Zydus |
3/28/2019 | Letairis | ambrisentan | Gilead | Sun |
3/29/2019 | Klor-Con | potassium chloride | Upsher-Smith | Pharmaceutics Int'l |
3/29/2019 | Azilect | rasagiline | Teva | Micro Labs |
4/1/2019 | Taxotere | docetaxel | Sanofi | Mylan |
4/1/2019 | Xyzal | levocetrizine | UCB | Hetero |
4/2/2019 | Marcaine | bupivacaine | Hospira | B. Braun |
4/2/2019 | BiCNU | carmustine | Emcure | STI Pharma |
4/4/2019 | Livalo | pitavastatin | Kowa | Mylan |
4/4/2019 | Pataday | olopatadine | Novartis | Aurobindo |
4/5/2019 | Acular | ketorolac | Allergan | Micro Labs |
4/5/2019 | Zantac | ranitidine | Glaxo | Appco |
4/8/2019 | Xenazine | tetrabenazine | Bausch | Hikma |
4/8/2019 | Anafril | clomipramine | SpecGx | Mankind |
4/9/2019 | Crestor | rosuvastatin | AstraZeneca | Umedica |
4/9/2019 | Makena | hydroxyprogesterone | AMAG | Sun |
4/10/2019 | Androgel 1.62% | testosterone | AbbVie | Lupin |
4/10/2019 | Naftine | naftifine | Sebela | Taro |
4/10/2019 | Letairis | ambrisentan | Gilead | Sigmapharm |
4/10/2019 | Letairis | ambrisentan | Gilead | Par |
4/10/2019 | Nexium | esomeprazole | AstraZeneca | Amneal |
4/10/2019 | Nitropress | sodium nitroprusside | Hospira | Dr. Reddy's Labs |
4/12/2019 | Lumigan 0.03% | bimatoprost | Allergan | Alembic |
4/15/2019 | Acticlate | doxycycline | Almirall | Apotex |
4/16/2019 | Makena | hydroxyprogesterone | AMAG | Eugia |
4/16/2019 | Tylenol | acetaminophen | Johnson & Johnson | Granules |
4/17/2019 | Lotemax | loteprednol | Bausch | Akorn |
4/17/2019 | Flonase | fluticasone | Glaxo | Akorn |
4/17/2019 | Evekeo | amphetamine | Arbor | Aurobindo |
4/19/2019 | Narcan | naloxone | Adapt | Teva |
4/19/2019 | Valstar | valrubicin | Endo | Custopharm |
4/19/2019 | Starlix | nateglinide | Novartis | Zydus |
4/19/2019 | Canasa | mesalamine | Teva | PSP |
4/19/2019 | Augmentin | amoxicillin / clavulanate potassium | Neopharma | Aurobindo |
4/19/2019 | Aubagio | teriflunomide | Sanofi | Alembic |
4/19/2019 | Afinitor Disperz | everolimus | Novartis | Mylan |
4/23/2019 | Banzel | rufinamide | Eisai | Hikma |
4/23/2019 | Banzel | rufinamide | Eisai | Bionpharma |
4/23/2019 | Concerta | methylphenidate | Johnson & Johnson | Lannett |
4/24/2019 | Depo-Testosterone | testosterone cypionate | Pfizer | Wilshire |
4/24/2019 | Nebupent | pentamidine | Fresenius Kabi | Seton |
4/24/2019 | Aubagio | teriflunomide | Sanofi | MSN |
4/24/2019 | Arava | leflunomide | Sanofi | Zydus |
4/24/2019 | Zyvox | linezolid | Pfizer | Celltrion |
4/26/2019 | Tracleer | bosentan | Actelion | Zydus |
4/26/2019 | Letairis | ambrisentan | Gilead | Cipla |
4/26/2019 | Tracleer | bosentan | Actelion | Par |
4/26/2019 | Tracleer | bosentan | Actelion | Alvogen |
4/26/2019 | Tracleer | bosentan | Actelion | Natco |
4/26/2019 | Tracleer | bosentan | Actelion | Teva |
4/26/2019 | Tracleer | bosentan | Actelion | Zydus |
4/26/2019 | Tracleer | bosentan | Actelion | Hikma |
4/26/2019 | Tracleer | bosentan | Actelion | Sun |
4/26/2019 | Tracleer | bosentan | Actelion | Amneal |
4/26/2019 | K-Tab | potassium chloride | AbbVie | Pharmaceutics Int'l |
4/29/2019 | Cialis | tadalafil | Eli Lilly | Mylan |
4/29/2019 | Pataday | olopatadine | Alcon | Alembic |
4/30/2019 | Klor-Con | potassium chloride | Upsher-Smith | Prinston |
4/30/2019 | Nitrostat | nitroglycerin | Pfizer | Alvogen |
5/1/2019 | Epivir | lamivudine | ViiV | Macleods |
5/1/2019 | Cubicin | daptomycin | Merck | Dr. Reddy’s Labs. |
5/3/2019 | Alkeran | melphalan | Akorn | US World Meds |
5/6/2019 | Voltaren | diclofenac | Glaxo | Mylan |
5/6/2019 | Trisenox | arsenic trioxide | Teva | STI Pharma |
5/6/2019 | Welchol | colesevelam | Daiichi Sankyo | Alkem |
5/6/2019 | Klor-Con | potassium chloride | Upsher-Smith | Belcher |
5/7/2019 | Pristiq | desvenlafaxine | Pfizer | IntelliPharmaceutics |
5/7/2019 | Cuprimine | penicillamine | Bausch | Amerigen |
5/7/2019 | Busulfex | busulfan | Otsuka | Apotex |
5/9/2019 | Nuvigil | armodafinil | Teva | Mylan |
5/10/2019 | Kuvan | sapropterin | Biomarin | Par |
5/10/2019 | Aleve PM | naproxen / diphenhydramine | Bayer | Perrigo |
5/10/2019 | Nexium | esomeprazole | AstraZeneca | Glenmark |
5/13/2019 | Actonel | risedronate | Allergan | Orchid |
5/13/2019 | Trandate | labetalol lotion | County Line | Zydus |
5/14/2019 | Albenza | albendazole | Amneal | Edenbridge |
5/15/2019 | Zometa | zoledronic acid | Novartis | Shilpa |
5/16/2019 | Taxotere | docetaxel | Sanofi | Shilpa |
5/16/2019 | Voltaren | diclofenac | Glaxo | Perrigo |
5/17/2019 | Latuda | lurasidone | Sunovion | Teva |
5/17/2019 | Sensipar | cinacalcet HCl | Amgen | Alkem |
5/17/2019 | Mycamine | micafungin | Astellas | Fresenius Kabi |
5/17/2019 | Astelin | azelastine | Mylan | Akorn |
5/17/2019 | Adderall XR | dextroamphetamine saccharate / amphetamine aspartate / dextroamphetamine sulfate / amphetamine sulfate | Shire | Sun |
5/17/2019 | Adderall XR | dextroamphetamine saccharate / amphetamine aspartate / dextroamphetamine sulfate / amphetamine sulfate | Shire | Rhodes |
5/20/2019 | Cosmegen | dactinomycin | Recordati | X-Gen |
5/20/2019 | Vesicare | solifenacin | Astellas | Ajanta |
5/20/2019 | Vesicare | solifenacin | Astellas | Alembic |
5/20/2019 | Vesicare | solifenacin | Astellas | Glenmark |
5/20/2019 | Vesicare | solifenacin | Astellas | Qilu |
5/20/2019 | Vesicare | solifenacin | Astellas | Amneal |
5/20/2019 | Vesicare | solifenacin | Astellas | Breckenridge |
5/20/2019 | Vesicare | solifenacin | Astellas | Cipla |
5/20/2019 | Vesicare | solifenacin | Astellas | Jiangxi Boya |
5/20/2019 | Vesicare | solifenacin | Astellas | Airis Pharma |
5/20/2019 | Vesicare | solifenacin | Astellas | ScieGen |
5/21/2019 | Ampyra | dalfampridine | Acorda | Sun |
5/22/2019 | Nexium | esomeprazole | AstraZeneca | Zydus |
5/22/2019 | Vitamin K | phytonadione | Hospira | Dr. Reddy’s Labs. |
5/22/2019 | Syprine | trientine | Aton | MSN |
5/24/2019 | Aggrenox | aspirin / dipyridamole | Boehringer-Ingelheim | Glenmark |
5/28/2019 | Ranexa | ranolazine | Gilead | Ajanta |
5/28/2019 | Ranexa | ranolazine | Gilead | Cipla |
5/28/2019 | Ranexa | ranolazine | Gilead | Sun |
5/31/2019 | Adderall XR | dextroamphetamine saccharate / amphetamine aspartate / dextroamphetamine sulfate / amphetamine sulfate | Shire | Par |
5/31/2019 | Felbatol | felbamate | Mylan | Vistapharm |
5/31/2019 | Revatio | sildenafil | Pfizer | Novitium |
6/3/2019 | Xibrom | bromfenac | Bausch | Pfizer |
6/3/2019 | Atripla | efavirenz / emtricitabine / tenofovir | Gilead | Cipla |
6/3/2019 | Arava | leflunomide | Sanofi | Abhai |
6/4/2019 | Ranexa | ranolazine | Gilead | ScieGen |
6/5/2019 | Sinemet CR | carbidopa/levodopa | Alembic | |
6/5/2019 | Nexium 24hr | esomeprazole | AstraZeneca | Amneal |
6/5/2019 | K-Tab | potassium chloride | AbbVie | Adare Pharms |
6/6/2019 | DDAVP | desmopressin | Ferring | Novast |
6/11/2019 | Tygacil | tigecycline | Pfizer | Aurobindo |
6/11/2019 | Klor-Con | potassium chloride | Upsher-Smith | Prinston |
6/12/2019 | Canasa | mesalamine | Allergan | Sandoz |
6/12/2019 | Invega | paliperidone | Johnson & Johnson | Inventia |
6/12/2019 | Claritin | loratadine | Bayer | Perrigo |
6/13/2019 | Cosopt | dorzolamide HCl / timolol maleate | Akorn | FDC |
6/14/2019 | Lovaza | omega-3-acid ethyl esters | Glaxo | Zydus |
6/14/2019 | Cardizem CD | diltiazem HCl | Bausch | Novast Labs |
6/17/2019 | K-Tab | potassium chloride | AbbVie | PII |
6/18/2019 | Dyloject | diclofenac sodium | Pfizer | Mylan |
6/18/2019 | Diamox | acetazolamide | Teva | Mylan |
6/19/2019 | Transderm Scop | scopolamine | Glaxo | Mylan |
6/19/2019 | Lumigan 0.03% | bimatoprost | Allergan | Somerset Therapeutics |
6/20/2019 | Cytovene | ganciclovir sodium | Roche | Custopharm |
6/20/2019 | Sodium Bicarbonate | sodium bicarbonate | Abbott Labs | Exela Pharma SCS |
6/21/2019 | Canasa | mesalamine | Allergan | Amring Pharms |
6/21/2019 | Xeloda | capecitabine | Hoffmann La Roche | Sun |
6/21/2019 | Dexedrine | dextroamphetamine sulfate | Impax Labs | PII |
6/21/2019 | Xibrom | bromfenac sodium | Bausch and Lomb | Alembic |
6/24/2019 | Tamiflu | oseltamivir phosphate | Gilead | Alembic |
6/24/2019 | Cubicin | daptomycin | Merck | Accord Healthcare |
6/24/2019 | Cuprimine | penicillamine | Valeant | Teva |
6/25/2019 | Cosopt | dorzolamide HCl / timolol maleate | Akorn | Somerset Therapeutics |
6/26/2019 | Aczone gel 7.5% | dapsone | Allergan | Taro |
6/26/2019 | Bethkis | tobramycin | Chiesi | Teva |
6/26/2019 | Bactrim | sulfamethoxazole / trimethoprim | Sun | Somerset Therapeutics |
6/26/2019 | Cubicin | daptomycin | Cubist | BE Pharms |
6/27/2019 | Vytorin | ezetimibe / simvastatin | Pfizer | Glenmark |
6/27/2019 | Medrol | methylprednisolone | Pharmancia and Upjohn | Sungen Pharma |
6/28/2019 | Sensipar | cinacalcet HCl | Amgen | Lupin |
6/28/2019 | Isuprel | isoproterenol HCl | Bausch | Cipla |
6/28/2019 | Ultram | tramadol HCl | Janssen | Rubicon |
6/28/2019 | Klonopin | clonazepam | Hoffmann La Roche | Alembic |
GENERICally Speaking Summer 2019
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