Agency Timeframes
| Country | Product | INN | Pharma Dosage Form | Strengths | Process | Submission Date | Approval Date Official Letter | Approval Time (days) |
|---|---|---|---|---|---|---|---|---|
| MÉXICO | RAAZID | Telmisartan + HCTZ | TABLET | 80 mg+12.5 mg 80 mg+25.0 mg | ACTUAL | 2023-01-16 | 2025-06-19 | 885 |
| MÉXICO | SENSIBIT | Loratadine | TABLET | 10 mg | RENEWAL | 2025-01-09 | 2025-01-09 | 0 |
| MÉXICO | SENSIBIT | Loratadine | TABLET | 10 mg | POST APPROVAL COMMITMENT | 2025-05-06 | 2025-05-15 | 9 |
| BRASIL | SENSIBIT D NF | Phenylephrine + Loratadine + Paracetamol | TABLET | 2.5 mg+5 mg+500 mg | ACTUAL | 2021-02-18 | 2022-06-17 | 484 |
| MÉXICO | SENSIBIT D NF | Phenylephrine + Loratadine + Paracetamol | TABLET | 2.5 mg+5 mg+500 mg | FREE TEXT | 2024-08-12 | 2025-07-17 | 339 |
| MÉXICO | SIIRRITAB | Trimebutine + Simeticone | TABLET | 100 mg+37.5 mg 200 mg+75 mg | ACTUAL | 2024-07-31 | 2025-12-04 | 491 |
| MÉXICO | THOREVA | Atorvastatine | TABLET | 10 mg 20 mg 40 mg 80 mg | MAJOR VARIATION | 2024-06-28 | 2025-11-27 | 517 |
| MÉXICO | TRONIUM IV | Esomeprazol | SOLUTION | 40 mg/5 mL | MODERATE VARIATION | 2025-07-09 | 2025-07-09 | 0 |
| MÉXICO | TRONIUM IV | Esomeprazol | SOLUTION | 40 mg/5 mL | LEGAL PROCESS | 2025-09-03 | 2025-09-19 | 16 |
| MÉXICO | TRONIUM IV | Esomeprazol | SOLUTION | 40 mg/5 mL | MAJOR VARIATION | 2021-10-01 | 2025-12-05 | 1526 |
| MÉXICO | UNILOID | Hydrocortisone | CREAM | 0.1 % | ACTUAL | 2025-07-15 | 2025-11-14 | 122 |
| MÉXICO | ANALGEN NF | Naproxen + Lidocaine | GEL | 10 g+5 g | RENEWAL | 2025-03-31 | 2025-09-09 | 162 |
| MÉXICO | CICLOFERON | Aciclovir | SOLUTION | NA | RENEWAL | 2024-10-03 | 2025-07-20 | 290 |
| MÉXICO | CICLOFERON | Aciclovir | SOLUTION (SPRAY) | 5 g/100 mL | RENEWAL | 2024-10-03 | 2025-08-03 | 304 |
| MÉXICO | FOSFONAT | Ibandronic acid | TABLET | NA | RENEWAL | 2024-12-05 | 2025-07-06 | 213 |
| MÉXICO | GLIPAMET | NA | MAJOR VARIATION | 2025-02-04 | 2025-11-10 | 279 | ||
| MÉXICO | GLIPA-MT | Sitagliptin + Metformin | TABLET | NA | TOLLING PERMIT | 2025-08-25 | 2025-08-25 | 0 |
| MÉXICO | GLITACAR-1 | Pioglitazone | TABLET | 15 mg 30 mg | RENEWAL | 2022-09-26 | 2023-10-30 | 399 |
| MÉXICO | L-OMBRIX-DUET | Mebendazole + Quinfamide | TABLET | NA | RENEWAL | 2025-01-31 | 2025-12-12 | 315 |
| MÉXICO | MICRORGAN | Ciprofloxacin | TABLET | 500 mg | RENEWAL | 2025-06-09 | 2026-01-20 | 225 |
| MÉXICO | MINOFEN | TABLET | NA | CANCELLATION | 2015-04-24 | 2016-03-04 | 315 | |
| MÉXICO | PRAZOLAN | Pantoprazol | SOLUTION | 40 mg | RENEWAL | 2024-12-18 | 2025-06-05 | 169 |
| MÉXICO | QUADRILOID | CREAM | NA | INTERNAL CORRECTION | 2024-02-10 | 2024-10-03 | 236 | |
| MÉXICO | RAAZID | Telmisartan+HCTZ | TABLET | NA | INTERNAL CORRECTION | 2025-07-08 | 2025-09-08 | 62 |
| MÉXICO | SOTAVENT | TABLET | NA | CANCELLATION | 2024-04-17 | 2025-01-20 | 278 | |
| MÉXICO | VIATOR-A | TABLET | NA | CANCELLATION | 2024-04-17 | 2025-11-04 | 566 | |
| MÉXICO | FACIDEX | Famotidine | TABLET | 10 mg | RENEWAL | 2025-08-22 | 2025-08-22 | 0 |
| MÉXICO | FLAGENASE | Metronidazole | ovule | 500 mg | MAJOR VARIATION | 2024-04-22 | 2024-08-09 | 109 |
| MÉXICO | FLAGENASE | Metronidazole | TABLET | 250 mg 500 mg | MAJOR VARIATION | 2023-08-01 | 2025-05-21 | 659 |
| MÉXICO | FLAGENASE 400 PEDIATRICO | Metronidazole + Diiodohydroxyquinoleine | SUSPENSION | 2.5 g+2 g/100 mL | RENEWAL | 2026-01-16 | 2026-01-16 | 0 |
| MÉXICO | INHIBITRON F | Omeprazole | CAPSULE | 40 mg | MAJOR VARIATION | 2024-06-28 | 2025-11-07 | 497 |
| MÉXICO | INHIBITRON F | Omeprazole | CAPSULE | 40 mg | FREE TEXT | 2024-08-09 | 2025-10-29 | 446 |
| COLOMBIA | L-OMBRIX-DUET | Mebendazole + Quinfamide | SUSPENSION | 60 mg+10 mg/mL 60 mg+20 mg/mL | ACTUAL | 2024-08-06 | 2025-11-12 | 463 |
| MÉXICO | L-OMBRIX-DUET | Mebendazole + Quinfamide | SUSPENSION | 1) 60 mg+10 mg/mL 2) 60 mg+20 mg/mL | MAJOR VARIATION | 2024-08-06 | 2025-11-12 | 463 |
| MÉXICO | MYCELVAN | Terbinafine | TABLET | 250 mg | RENEWAL | 2026-01-08 | 2026-01-08 | 0 |
| MÉXICO | PRAZOLAN | Pantoprazol | TABLET | 40 mg | MAJOR VARIATION | 2025-09-11 | 2025-09-24 | 13 |
| MÉXICO | PRAZOLAN | Pantoprazol | TABLET | 40 mg | MAJOR VARIATION | 2025-09-18 | 2025-09-24 | 6 |
| MÉXICO | PROSIQUE | Fluoxetine | CAPSULE | 20 mg | RENEWAL | 2025-10-24 | 2025-10-24 | 0 |
| MÉXICO | QUIMARA-1 | Imiquimod | CREAM | 50 mg/g | FREE TEXT | 2024-08-09 | 2025-07-17 | 342 |
| MÉXICO | QUIMARA-1 | Imiquimod | CREAM | 50 mg/g | MAJOR VARIATION | 2024-04-22 | 2025-12-19 | 606 |
| MÉXICO | RAAS | Telmisartan | TABLET | 40 mg 80 mg | MAJOR VARIATION | 2020-11-09 | 2025-01-20 | 1533 |
| MÉXICO | ANALGEN | Naproxen | TABLET | 550 mg+220 mg | RENEWAL | 2025-12-19 | 2025-12-19 | 0 |
| MÉXICO | BOLT 36 | Tadalafil | TABLET | 5 mg 20 mg | MAJOR VARIATION | 2023-01-30 | 2024-06-23 | 510 |
| MÉXICO | CANDIDERM | Clortrimazole | CREAM | 2 g | ANDA | 2024-12-17 | 2025-12-04 | 352 |
| MÉXICO | CANDIFLUX | Fluconazole | CAPSULE | 150 mg | RENEWAL | 2025-11-28 | 2025-11-28 | 0 |
| MÉXICO | CO-DEGREGAN | Clopidogrel bisulfate + Acetylsalicylic acid | TABLET | 75 mg+100 mg | FIRST RENEWAL | 2025-09-29 | 2025-10-28 | 29 |
| COLOMBIA | CONTINENTAL | Solifenacine | TABLET | 5 mg 10 mg | ACTUAL | 2021-01-14 | 2024-06-12 | 1245 |
| MÉXICO | CONTINENTAL | Solifenacine | TABLET | 5 mg 10 mg | MAJOR VARIATION | 2021-01-14 | 2024-06-12 | 1245 |
| MÉXICO | CONTINENTAL | Solifenacine | TABLET | 5 mg 10 mg | RENEWAL | 2021-06-17 | 2022-07-27 | 405 |
| BRASIL | DAFLOXEN | Naproxen sodium | TABLET | 275 mg 550 mg | ACTUAL | 2020-11-20 | 2024-06-28 | 1316 |
| MÉXICO | DAPOSAR | Dapagliflozine | TABLET | 10 mg | ACTUAL | 2023-03-28 | 2025-03-21 | 724 |
| MÉXICO | DOSCOXEL | Etoricoxib | TABLET | 60 mg 90 mg 120 mg | MAJOR VARIATION | 2024-04-30 | 2025-10-22 | 540 |
| MÉXICO | DOSCOXEL | Etoricoxib | TABLET | 60 mg 90 mg 120 mg | FREE TEXT | 2025-06-10 | 2025-10-22 | 134 |
| MÉXICO | DOSCOXEL | Etoricoxib | TABLET | 60 mg 90 mg 120 mg | FREE TEXT | 2024-08-09 | 2025-10-22 | 439 |
| MÉXICO | EVEREST | Montelukast | TABLET | 10 mg | ACTUAL | 2021-12-01 | 2021-12-15 | 14 |
| MÉXICO | EVEREST | Montelukast | TABLET | 10 mg | INTERNAL CORRECTION | 2020-12-17 | 2021-12-15 | 363 |