Home Applications 208039 Application 208039
Type ANDA
Sponsor AUROBINDO PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE No No 002 DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE No No 003 DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208039-001 DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2025-05-14 A208039-002 DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL AB 2025-05-14 A208039-003 DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2025-05-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 A208039-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2025-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208039-002 DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL AB 2025-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208039-003 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2025-05-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208039-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2025-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208039-002 DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL AB 2025-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208039-003 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2025-05-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208039-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2025-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208039-002 DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL AB 2025-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208039-003 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2025-05-14 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208039-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2025-05-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208039-002 DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL AB 2025-05-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208039-003 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2025-05-14 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.