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REGULATORY AFFAIRS DATABASE

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Country Product INN Strengths Pharma Dosage Form Process SubmissionDateActual ApprovalDate LaunchDateActual
MÉXICO RAAZID Telmisartan + HCTZ 80 mg+12.5 mg 80 mg+25.0 mg TABLET ACTUAL 16/01/2023 - -
MÉXICO SELTAFERON Oseltamivir 6 mg/mL SUSPENSION MAJOR VARIATION 30/10/2024 - -
MÉXICO SENSIBIT Loratadine 10 mg TABLET RENEWAL 09/01/2025 - -
MÉXICO SENSIBIT Loratadine 10 mg TABLET POST APPROVAL COMMITMENT 06/05/2025 - -
BRASIL SENSIBIT D NF Phenylephrine + Loratadine + Paracetamol 2.5 mg+5 mg+500 mg TABLET ACTUAL 18/02/2021 - -
MÉXICO SENSIBIT D NF Phenylephrine + Loratadine + Paracetamol 2.5 mg+5 mg+500 mg TABLET FREE TEXT 12/08/2024 - -
MÉXICO SIIRRITAB Trimebutine + Simeticone 100 mg+37.5 mg 200 mg+75 mg TABLET ACTUAL 31/07/2024 - -
MÉXICO SUPRADOL Ketorolac tromethamine 30 mg/mL 60 mg/2 mL INJECTABLE SOLUTION MAJOR VARIATION 30/10/2025 - -
MÉXICO THOREVA Atorvastatine 10 mg 20 mg 40 mg 80 mg TABLET MAJOR VARIATION 28/06/2024 - -
MÉXICO THOREVA Atorvastatine 10 mg 20 mg 40 mg 80 mg TABLET INTERNAL CORRECTION 13/01/2026 - -
MÉXICO TRONIUM Esomeprazol 20 mg CAPSULE ANDA 26/11/2024 - -
MÉXICO TRONIUM IV Esomeprazol 40 mg/5 mL SOLUTION MODERATE VARIATION 09/07/2025 - -
MÉXICO TRONIUM IV Esomeprazol 40 mg/5 mL SOLUTION LEGAL PROCESS 03/09/2025 - -
MÉXICO TRONIUM IV Esomeprazol 40 mg/5 mL SOLUTION MAT - - -
MÉXICO TRONIUM IV Esomeprazol 40 mg/5 mL SOLUTION RENEWAL - - -
MÉXICO TRONIUM IV Esomeprazol 40 mg/5 mL SOLUTION MAJOR VARIATION 01/10/2021 - -
MÉXICO TRONIUM IV Esomeprazol 40 mg/5 mL SOLUTION MAJOR VARIATION 16/12/2024 - -
MÉXICO TRONIUM IV Esomeprazol 40 mg/5 mL SOLUTION MAJOR VARIATION 01/10/2021 - -
MÉXICO TUSIGEN NF Ambroxol + Dextromethorphan 22.5 mg+22.500 g TABLET MAJOR VARIATION 11/04/2022 - -
MÉXICO UNILOID Hydrocortisone 0.1 % CREAM ACTUAL 15/07/2025 - -
MÉXICO ZOLNIC Zoledronic acid 4 mg/5 mL SOLUTION MAJOR VARIATION 19/12/2025 - -
MÉXICO QUIMARA-1 Imiquimod 50 mg/g CREAM INTERNAL CORRECTION 22/01/2026 - -
MÉXICO ANALGEN NF Naproxen + Lidocaine 10 g+5 g GEL RENEWAL 31/03/2025 - -
MÉXICO CICLOFERON Aciclovir NA SOLUTION RENEWAL 03/10/2024 - -
MÉXICO CICLOFERON Aciclovir 5 g/100 mL SOLUTION (SPRAY) RENEWAL 03/10/2024 - -
MÉXICO FOSFONAT Ibandronic acid NA TABLET RENEWAL 05/12/2024 - -
MÉXICO GLIPAMET - NA - MAJOR VARIATION 04/02/2025 - -
MÉXICO GLIPA-MT Sitagliptin + Metformin NA TABLET TOLLING PERMIT 25/08/2025 - -
MÉXICO GLITACAR-1 Pioglitazone 15 mg 30 mg TABLET RENEWAL 26/09/2022 - -
MÉXICO L-OMBRIX-DUET Mebendazole + Quinfamide NA TABLET RENEWAL 31/01/2025 - -
MÉXICO MICRORGAN Ciprofloxacin 500 mg TABLET RENEWAL 09/06/2025 - -
MÉXICO MINOFEN - NA TABLET CANCELLATION 24/04/2015 - -
MÉXICO PRAZOLAN Pantoprazol 40 mg SOLUTION RENEWAL 18/12/2024 - -
MÉXICO QUADRILOID - NA CREAM INTERNAL CORRECTION 10/02/2024 - -
MÉXICO RAAZID Telmisartan+HCTZ NA TABLET INTERNAL CORRECTION 08/07/2025 - -
MÉXICO SOTAVENT - NA TABLET CANCELLATION 17/04/2024 - -
MÉXICO VIATOR-A - NA TABLET CANCELLATION 17/04/2024 - -
MÉXICO EVEREST Montelukast 10 mg TABLET MAJOR VARIATION 16/12/2022 - -
MÉXICO EVOCS-III Levofloxacin 500 mg 750 mg TABLET MAJOR VARIATION 07/12/2022 - -
MÉXICO FACIDEX Famotidine 10 mg TABLET RENEWAL 22/08/2025 - -
MÉXICO FACIDEX Famotidine 10 mg TABLET CANCELLATION 08/07/2015 - -
MÉXICO FLAGENASE Metronidazole 500 mg ovule MAJOR VARIATION 22/04/2024 - -
MÉXICO FLAGENASE Metronidazole 250 mg 500 mg TABLET MAJOR VARIATION 01/08/2023 - -
MÉXICO FLAGENASE Metronidazole 500 mg ovule LEGAL PROCESS - - -
MÉXICO FLAGENASE 400 PEDIATRICO Metronidazole + Diiodohydroxyquinoleine 2.5 g+2 g/100 mL SUSPENSION RENEWAL 16/01/2026 - -
MÉXICO FOCINAT Calcium + Cholecalciferol 315 mg/200 UI TABLET FIRST RENEWAL 06/12/2022 - -
MÉXICO GLITACAR-1 Pioglitazone 15 mg 30 mg TABLET MAJOR VARIATION - - -
MÉXICO INHIBITRON Omeprazole 40 mg/ 10mL SOLUTION POST APPROVAL COMMITMENT 13/09/2024 - -
MÉXICO INHIBITRON Omeprazole 1) 10 mg 2) 20 mg CAPSULE MAJOR VARIATION 23/07/2024 - -
MÉXICO INHIBITRON F Omeprazole 40 mg CAPSULE MAJOR VARIATION 28/06/2024 - -
MÉXICO INHIBITRON F Omeprazole 40 mg CAPSULE FREE TEXT 09/08/2024 - -
COLOMBIA L-OMBRIX-DUET Mebendazole + Quinfamide 60 mg+10 mg/mL 60 mg+20 mg/mL SUSPENSION ACTUAL 06/08/2024 - -
MÉXICO L-OMBRIX-DUET Mebendazole + Quinfamide 1) 60 mg+10 mg/mL 2) 60 mg+20 mg/mL SUSPENSION MAJOR VARIATION 06/08/2024 - -
MÉXICO MICRORGAN Ciprofloxacin 500 mg TABLET MAJOR VARIATION 09/12/2025 - -
MÉXICO MUCOVIBROL Ambroxol 0.300 g/100 mL 0.750 g/100 mL SOLUTION MAJOR VARIATION - - -
MÉXICO MUCOVIBROL Ambroxol 0.300 g/100 mL 0.750 g/100 mL SOLUTION PROMOTIONAL PERMIT - - -
MÉXICO MUCOVIBROL Ambroxol 0.300 g/100 mL 0.750 g/100 mL SOLUTION PROMOTIONAL PERMIT - - -
MÉXICO MUCOVIBROL Ambroxol 30 mg TABLET MAJOR VARIATION 20/09/2024 - -
MÉXICO MUCOVIBROL Ambroxol 0.300 g/100 mL 0.750 g/100 mL SOLUTION MAJOR VARIATION 03/09/2025 - -
MÉXICO MYCELVAN Terbinafine 0.888 g SPRAY ANDA 21/03/2024 - -
MÉXICO MYCELVAN Terbinafine 250 mg TABLET RENEWAL 08/01/2026 - -
MÉXICO PRAZOLAN Pantoprazol 40 mg TABLET MAJOR VARIATION 11/09/2025 - -
MÉXICO PRAZOLAN Pantoprazol 40 mg TABLET MAJOR VARIATION 18/09/2025 - -
MÉXICO PRAZOLAN Pantoprazol 40 mg TABLET MAJOR VARIATION 29/10/2021 - -
MÉXICO PRAZOLAN Pantoprazol 40 mg TABLET MAJOR VARIATION 17/06/2021 - -
MÉXICO PRAZOLAN Pantoprazol 40 mg SOLUTION MAJOR VARIATION 28/10/2024 - -
MÉXICO PROSIQUE Fluoxetine 20 mg CAPSULE RENEWAL 24/10/2025 - -
MÉXICO QUIMARA-1 Imiquimod 50 mg/g CREAM FREE TEXT 09/08/2024 - -
MÉXICO QUIMARA-1 Imiquimod 50 mg/g CREAM MAJOR VARIATION 22/04/2024 - -
MÉXICO RAAS Telmisartan 40 mg 80 mg TABLET MAJOR VARIATION 09/11/2020 - -
MÉXICO ALESSE-1 Levonorgestrel 0.75 mg TABLET RENEWAL - - -
MÉXICO ANALGEN Naproxen 10 g/100 g GEL RENEWAL - - -
MÉXICO ANALGEN Naproxen 550 mg+220 mg TABLET RENEWAL 19/12/2025 - -
MÉXICO ANALGEN FEM Naproxen + Paracetamol + Pamabrom 220 mg+300 mg+25 mg TABLET MAJOR VARIATION 07/04/2021 - -
MÉXICO ANALGEN NF Naproxen + Lidocaine 10 g+5 g GEL GMP 06/11/2025 - -
MÉXICO ASA 500 Acetylsalicilic acid 500 mg CAPSULE RENEWAL - - -
MÉXICO BOLT 36 Tadalafil 5 mg 20 mg TABLET RENEWAL - - -
MÉXICO BOLT 36 Tadalafil 20 mg Gel FIRST RENEWAL 14/06/2025 - -
MÉXICO BOLT 36 Tadalafil 20 mg Gel MAJOR VARIATION 07/06/2021 - -
MÉXICO BOLT 36 Tadalafil 20 mg Gel MAJOR VARIATION 06/08/2024 - -
MÉXICO BOLT 36 Tadalafil 5 mg 20 mg TABLET MAJOR VARIATION 30/01/2023 - -
MÉXICO CANDIDERM Clortrimazole 2 g CREAM ANDA 17/12/2024 - -
MÉXICO CANDIFLUX Fluconazole 150 mg CAPSULE RENEWAL 28/11/2025 - -
MÉXICO CEFTRIANOL Ceftriaxone 1 g SOLUTION MAJOR VARIATION - - -
MÉXICO CICLOFERON Aciclovir 200 mg 400 mg TABLET RENEWAL - - -
MÉXICO CICLOFERON Aciclovir 4 g/100 mL SUSPENSION MAJOR VARIATION 16/10/2025 - -
MÉXICO CILIOSTEN Miconazole 2 g POWDER RENEWAL - - -
MÉXICO CO-DEGREGAN Clopidogrel bisulfate + Acetylsalicylic acid 75 mg+100 mg TABLET FIRST RENEWAL 29/09/2025 - -
MÉXICO CO-DEGREGAN Clopidogrel bisulfate + Acetylsalicylic acid 75 mg+100 mg TABLET MAJOR VARIATION - - -
MÉXICO CONAZOL TALCO Ketoconazole 2 g/100 g 0.02 g/g POWDER RENEWAL - - -
COLOMBIA CONTINENTAL Solifenacine 5 mg 10 mg TABLET ACTUAL 14/01/2021 - -
MÉXICO CONTINENTAL Solifenacine 5 mg 10 mg TABLET MAJOR VARIATION 14/01/2021 - -
MÉXICO CONTINENTAL Solifenacine 5 mg 10 mg TABLET RENEWAL 17/06/2021 - -
BRASIL DAFLOXEN Naproxen sodium 275 mg 550 mg TABLET ACTUAL 20/11/2020 - -
MÉXICO DAKART Dutasteride + Tamsulosin 0.5 mg+0.4 mg CAPSULE MAJOR VARIATION 28/01/2026 - -
MÉXICO DAKART Dutasteride + Tamsulosin 0.5 mg+0.4 mg CAPSULE RENEWAL 08/12/2025 - -
MÉXICO DAPOSAR Dapagliflozine 10 mg TABLET ACTUAL 28/03/2023 - -
MÉXICO DAPOSAR Dapagliflozine 10 mg TABLET MAJOR VARIATION 19/12/2025 - -
MÉXICO DOSCOXEL Etoricoxib 60 mg 90 mg 120 mg TABLET MAJOR VARIATION 30/04/2024 - -
MÉXICO DOSCOXEL Etoricoxib 60 mg 90 mg 120 mg TABLET FREE TEXT 10/06/2025 - -
MÉXICO DOSCOXEL Etoricoxib 60 mg 90 mg 120 mg TABLET FREE TEXT 09/08/2024 - -
MÉXICO DOSCOXEL-DUO Etoricoxib + Tramadol 120 mg+100 mg TABLET MAJOR VARIATION 20/03/2025 - -
MÉXICO ECTAPRIM Trimethoprim + Sulfamethoxazole 80 mg+400 mg TABLET MAJOR VARIATION 30/04/2024 - -
MÉXICO EVEREST Montelukast 10 mg TABLET ACTUAL 01/12/2021 - -
MÉXICO EVEREST Montelukast 10 mg TABLET RENEWAL - - -
MÉXICO EVEREST Montelukast 10 mg TABLET INTERNAL CORRECTION 17/12/2020 - -