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ANDA Approvals
Summer 2019
| 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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