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$MYL News

Last published 1mo ago

  • 1mo agoMYLApproval of Carbidopa And Levodopa, Anda #075091 (Labeling)FDA Approved DrugsApproval Date: 10/08/2026; Drug Name: Carbidopa And Levodopa, Anda #075091; Active Ingredients: CARBIDOPA; LEVODOPA; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 075091
  • 1mo agoMYLApproval of Clozapine, Anda #075417 (Labeling)FDA Approved DrugsApproval Date: 10/02/2026; Drug Name: Clozapine, Anda #075417; Active Ingredients: CLOZAPINE; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 075417
  • 1mo agoMYLApproval of Spironolactone, Anda #040424 (Labeling)FDA Approved DrugsApproval Date: 09/23/2026; Drug Name: Spironolactone, Anda #040424; Active Ingredients: SPIRONOLACTONE; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 040424
  • 2mo agoMYLApproval of Nevirapine, Anda #205651 (Labeling)FDA Approved DrugsApproval Date: 09/01/2026; Drug Name: Nevirapine, Anda #205651; Active Ingredients: NEVIRAPINE; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 205651
  • 3mo agoMYLApproval of Metformin Hydrochloride, Anda #075973 (Labeling)FDA Approved DrugsApproval Date: 08/11/2026; Drug Name: Metformin Hydrochloride, Anda #075973; Active Ingredients: METFORMIN HYDROCHLORIDE; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 075973
  • 3mo agoMYLApproval of Saxagliptin And Metformin Hydrochloride, Anda #205981 (Labeling)FDA Approved DrugsApproval Date: 08/04/2026; Drug Name: Saxagliptin And Metformin Hydrochloride, Anda #205981; Active Ingredients: METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 205981
  • 3mo agoMYLApproval of Mycophenolate Mofetil, Anda #065521 (REMS)FDA Approved DrugsApproval Date: 07/29/2026; Drug Name: Mycophenolate Mofetil, Anda #065521; Active Ingredients: MYCOPHENOLATE MOFETIL; Company: Mylan; Submission Status: Approval; Submission Classification: REMS; Application Number: 065521
  • 3mo agoMYLApproval of Mycophenolate Mofetil, Anda #065520 (REMS)FDA Approved DrugsApproval Date: 07/29/2026; Drug Name: Mycophenolate Mofetil, Anda #065520; Active Ingredients: MYCOPHENOLATE MOFETIL; Company: Mylan; Submission Status: Approval; Submission Classification: REMS; Application Number: 065520
  • 4mo agoMYLApproval of Amlodipine Besylate And Atorvastatin Calcium, Anda #200465 (Labeling)FDA Approved DrugsApproval Date: 06/25/2026; Drug Name: Amlodipine Besylate And Atorvastatin Calcium, Anda #200465; Active Ingredients: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 200465
  • 4mo agoMYLApproval of Ferric Carboxymaltose, Anda #217769FDA Approved DrugsApproval Date: 06/25/2026; Drug Name: Ferric Carboxymaltose, Anda #217769; Active Ingredients: FERRIC CARBOXYMALTOSE; Company: Mylan; Submission Status: Approval; Application Number: 217769
  • 4mo agoMYLApproval of Tramadol Hydrochloride, Anda #205257 (REMS)FDA Approved DrugsApproval Date: 06/18/2026; Drug Name: Tramadol Hydrochloride, Anda #205257; Active Ingredients: TRAMADOL HYDROCHLORIDE; Company: Mylan; Submission Status: Approval; Submission Classification: REMS; Application Number: 205257
  • 5mo agoMYLApproval of Divalproex Sodium, Anda #077567 (Labeling)FDA Approved DrugsApproval Date: 06/12/2026; Drug Name: Divalproex Sodium, Anda #077567; Active Ingredients: DIVALPROEX SODIUM; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 077567
  • 5mo agoMYLApproval of Methotrexate Sodium, Anda #081235 (Labeling)FDA Approved DrugsApproval Date: 05/27/2026; Drug Name: Methotrexate Sodium, Anda #081235; Active Ingredients: METHOTREXATE SODIUM; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 081235
  • 6mo agoMYLApproval of Pomalidomide, Anda #210275 (REMS)FDA Approved DrugsApproval Date: 04/27/2026; Drug Name: Pomalidomide, Anda #210275; Active Ingredients: POMALIDOMIDE; Company: Mylan; Submission Status: Approval; Submission Classification: REMS; Application Number: 210275
  • 6mo agoMYLApproval of Lenalidomide, Anda #213912 (REMS)FDA Approved DrugsApproval Date: 04/27/2026; Drug Name: Lenalidomide, Anda #213912; Active Ingredients: LENALIDOMIDE; Company: Mylan; Submission Status: Approval; Submission Classification: REMS; Application Number: 213912
  • 8mo agoMYLApproval of Aprepitant, Anda #218851FDA Approved DrugsApproval Date: 03/05/2026; Drug Name: Aprepitant, Anda #218851; Active Ingredients: APREPITANT; Company: Mylan; Submission Status: Approval; Application Number: 218851
  • 9mo agoMYLApproval of Doxycycline Hyclate, Anda #062432 (Labeling)FDA Approved DrugsApproval Date: 01/18/2026; Drug Name: Doxycycline Hyclate, Anda #062432; Active Ingredients: DOXYCYCLINE HYCLATE; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 062432
  • 10mo agoMYLApproval of Norgestimate And Ethinyl Estradiol, Anda #201896 (Labeling)FDA Approved DrugsApproval Date: 01/07/2026; Drug Name: Norgestimate And Ethinyl Estradiol, Anda #201896; Active Ingredients: ETHINYL ESTRADIOL; NORGESTIMATE; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 201896
  • 10mo agoMYLApproval of Tramadol Hydrochloride, Anda #205257 (Labeling)FDA Approved DrugsApproval Date: 12/23/2025; Drug Name: Tramadol Hydrochloride, Anda #205257; Active Ingredients: TRAMADOL HYDROCHLORIDE; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 205257
  • 1y agoMYLApproval of Linagliptin, Anda #208431FDA Approved DrugsApproval Date: 11/03/2025; Drug Name: Linagliptin, Anda #208431; Active Ingredients: LINAGLIPTIN; Company: Mylan; Submission Status: Approval; Application Number: 208431
  • 1y agoMYLApproval of Pomalidomide, Anda #210275 (Labeling)FDA Approved DrugsApproval Date: 10/17/2025; Drug Name: Pomalidomide, Anda #210275; Active Ingredients: POMALIDOMIDE; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 210275
  • 1y agoMYLApproval of Paclitaxel, Anda #217877FDA Approved DrugsApproval Date: 08/19/2025; Drug Name: Paclitaxel, Anda #217877; Active Ingredients: PACLITAXEL; Company: Mylan; Submission Status: Approval; Application Number: 217877
  • 1y agoMYLApproval of Ambrisentan, Anda #208441 (Labeling)FDA Approved DrugsApproval Date: 07/25/2025; Drug Name: Ambrisentan, Anda #208441; Active Ingredients: AMBRISENTAN; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 208441
  • 1y agoMYLApproval of Alprazolam, Anda #074215 (Labeling)FDA Approved DrugsApproval Date: 07/03/2025; Drug Name: Alprazolam, Anda #074215; Active Ingredients: ALPRAZOLAM; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 074215
  • 1y agoMYLApproval of Perphenazine And Amitriptyline Hydrochloride, Anda #071443 (Labeling)FDA Approved DrugsApproval Date: 06/24/2025; Drug Name: Perphenazine And Amitriptyline Hydrochloride, Anda #071443; Active Ingredients: AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 071443
  • 1y agoMYLApproval of Clozapine, Anda #201824 (Labeling)FDA Approved DrugsApproval Date: 06/13/2025; Drug Name: Clozapine, Anda #201824; Active Ingredients: CLOZAPINE; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 201824
  • 1y agoMYLApproval of Clozapine, Anda #075417 (REMS)FDA Approved DrugsApproval Date: 06/13/2025; Drug Name: Clozapine, Anda #075417; Active Ingredients: CLOZAPINE; Company: Mylan; Submission Status: Approval; Submission Classification: REMS; Application Number: 075417
  • 1y agoMYLApproval of Clozapine, Anda #201824 (REMS)FDA Approved DrugsApproval Date: 06/13/2025; Drug Name: Clozapine, Anda #201824; Active Ingredients: CLOZAPINE; Company: Mylan; Submission Status: Approval; Submission Classification: REMS; Application Number: 201824
  • 1y agoMYLApproval of Emtricitabine, Rilpivirine And Tenofovir Disoproxil Fumarate, Anda #208452FDA Approved DrugsApproval Date: 05/20/2025; Drug Name: Emtricitabine, Rilpivirine And Tenofovir Disoproxil Fumarate, Anda #208452; Active Ingredients: EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE; Company: Mylan; Submission Status: Approval; Application Number: 208452
  • 1y agoMYLApproval of Abiraterone Acetate, Anda #208446 (Manufacturing (CMC))FDA Approved DrugsApproval Date: 05/19/2025; Drug Name: Abiraterone Acetate, Anda #208446; Active Ingredients: ABIRATERONE ACETATE; Company: Mylan; Submission Status: Approval; Submission Classification: Manufacturing (CMC); Application Number: 208446
  • 1y agoMYLApproval of Diltiazem Hydrochloride, Anda #074910 (Labeling)FDA Approved DrugsApproval Date: 05/06/2025; Drug Name: Diltiazem Hydrochloride, Anda #074910; Active Ingredients: DILTIAZEM HYDROCHLORIDE; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 074910
  • 1y agoMYLApproval of Levothyroxine Sodium, Anda #076187 (Labeling)FDA Approved DrugsApproval Date: 05/01/2025; Drug Name: Levothyroxine Sodium, Anda #076187; Active Ingredients: LEVOTHYROXINE SODIUM; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 076187
  • 1y agoMYLApproval of Almotriptan Malate, Anda #205171 (Labeling)FDA Approved DrugsApproval Date: 04/15/2025; Drug Name: Almotriptan Malate, Anda #205171; Active Ingredients: ALMOTRIPTAN MALATE; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 205171
  • 1y agoMYLApproval of Ambrisentan, Anda #208441 (REMS)FDA Approved DrugsApproval Date: 04/04/2025; Drug Name: Ambrisentan, Anda #208441; Active Ingredients: AMBRISENTAN; Company: Mylan; Submission Status: Approval; Submission Classification: REMS; Application Number: 208441
  • 1y agoMYLApproval of Ticagrelor, Anda #208597 (Labeling)FDA Approved DrugsApproval Date: 04/04/2025; Drug Name: Ticagrelor, Anda #208597; Active Ingredients: TICAGRELOR; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 208597
  • 1y agoMYLApproval of Tacrolimus, Anda #090596 (Labeling)FDA Approved DrugsApproval Date: 02/20/2025; Drug Name: Tacrolimus, Anda #090596; Active Ingredients: TACROLIMUS; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 090596
  • 1y agoMYLApproval of Mercaptopurine, Anda #040594 (Labeling)FDA Approved DrugsApproval Date: 02/14/2025; Drug Name: Mercaptopurine, Anda #040594; Active Ingredients: MERCAPTOPURINE; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 040594
  • 1y agoMYLApproval of Levetiracetam, Anda #090261 (Labeling)FDA Approved DrugsApproval Date: 02/10/2025; Drug Name: Levetiracetam, Anda #090261; Active Ingredients: LEVETIRACETAM; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 090261
  • 1y agoMYLApproval of Levetiracetam, Anda #076919 (Labeling)FDA Approved DrugsApproval Date: 02/10/2025; Drug Name: Levetiracetam, Anda #076919; Active Ingredients: LEVETIRACETAM; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 076919
  • 1y agoMYLApproval of Dabigatran Etexilate Mesylate, Anda #208067FDA Approved DrugsApproval Date: 02/03/2025; Drug Name: Dabigatran Etexilate Mesylate, Anda #208067; Active Ingredients: DABIGATRAN ETEXILATE MESYLATE; Company: Mylan; Submission Status: Approval; Application Number: 208067
  • 1y agoMYLApproval of Trifluoperazine Hydrochloride, Anda #040209 (Labeling)FDA Approved DrugsApproval Date: 01/14/2025; Drug Name: Trifluoperazine Hydrochloride, Anda #040209; Active Ingredients: TRIFLUOPERAZINE HYDROCHLORIDE; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 040209
  • 1y agoMYLApproval of Imatinib Mesylate, Anda #204644 (Labeling)FDA Approved DrugsApproval Date: 12/09/2024; Drug Name: Imatinib Mesylate, Anda #204644; Active Ingredients: IMATINIB MESYLATE; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 204644
  • 1y agoMYLApproval of Aripiprazole, Anda #216608FDA Approved DrugsApproval Date: 12/03/2024; Drug Name: Aripiprazole, Anda #216608; Active Ingredients: ARIPIPRAZOLE; Company: Mylan; Submission Status: Approval; Application Number: 216608
  • 1y agoMYLApproval of Ketoprofen, Anda #075679 (Labeling)FDA Approved DrugsApproval Date: 11/21/2024; Drug Name: Ketoprofen, Anda #075679; Active Ingredients: KETOPROFEN; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 075679
  • 1y agoMYLApproval of Indomethacin, Anda #202139 (Labeling)FDA Approved DrugsApproval Date: 11/21/2024; Drug Name: Indomethacin, Anda #202139; Active Ingredients: INDOMETHACIN; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 202139
  • 1y agoMYLApproval of Ketorolac Tromethamine, Anda #074761 (Labeling)FDA Approved DrugsApproval Date: 11/21/2024; Drug Name: Ketorolac Tromethamine, Anda #074761; Active Ingredients: KETOROLAC TROMETHAMINE; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 074761
  • 1y agoMYLApproval of Meclofenamate Sodium, Anda #071081 (Labeling)FDA Approved DrugsApproval Date: 11/21/2024; Drug Name: Meclofenamate Sodium, Anda #071081; Active Ingredients: MECLOFENAMATE SODIUM; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 071081
  • 2y agoMYLApproval of Esomeprazole Magnesium, Anda #078936 (Labeling)FDA Approved DrugsApproval Date: 11/12/2024; Drug Name: Esomeprazole Magnesium, Anda #078936; Active Ingredients: ESOMEPRAZOLE MAGNESIUM; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 078936
  • 2y agoMYLApproval of Mesalamine, Anda #204354 (Labeling)FDA Approved DrugsApproval Date: 11/07/2024; Drug Name: Mesalamine, Anda #204354; Active Ingredients: MESALAMINE; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 204354
  • 2y agoMYLApproval of Esomeprazole Sodium, Anda #202686 (Labeling)FDA Approved DrugsApproval Date: 10/11/2024; Drug Name: Esomeprazole Sodium, Anda #202686; Active Ingredients: ESOMEPRAZOLE SODIUM; Company: Mylan; Submission Status: Approval; Submission Classification: Labeling; Application Number: 202686