Home Applications 217490 Application 217490
Type ANDA
Sponsor ALKEM LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE TABLET;ORAL EQ 40MG MEDOXOMIL;12.5MG No No 002 AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE TABLET;ORAL EQ 40MG MEDOXOMIL;25MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217490-001 AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL AB 2025-01-21 A217490-002 AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE EQ 40MG MEDOXOMIL;25MG TABLET / ORAL AB 2025-01-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A217490-001 AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL AB 2025-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217490-002 AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE EQ 40MG MEDOXOMIL;25MG TABLET / ORAL AB 2025-01-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217490-001 AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL AB 2025-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217490-002 AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE EQ 40MG MEDOXOMIL;25MG TABLET / ORAL AB 2025-01-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217490-001 AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL AB 2025-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217490-002 AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE EQ 40MG MEDOXOMIL;25MG TABLET / ORAL AB 2025-01-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217490-001 AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL AB 2025-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217490-002 AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE EQ 40MG MEDOXOMIL;25MG TABLET / ORAL AB 2025-01-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217490-001 AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL AB 2025-01-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217490-002 AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE EQ 40MG MEDOXOMIL;25MG TABLET / ORAL AB 2025-01-21 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217490-001 AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE EQ 40MG MEDOXOMIL;12.5MG TABLET / ORAL AB 2025-01-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217490-002 AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE EQ 40MG MEDOXOMIL;25MG TABLET / ORAL AB 2025-01-21 a50c72e98297…
Observed Orange Book normalized TE history# Documents# Document, Submission type, Date table Document Submission type Date 76819 ORIG 2025-02-24