Home Applications 207922 Application 207922
Type ANDA
Sponsor BRECKENRIDGE PHARMS 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 110MG No No 003 DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL 150MG 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 A207922-001 DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL 2024-12-19 A207922-002 DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL 2024-12-19 A207922-003 DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL 2024-12-19
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 A207922-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL 2024-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207922-002 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL 2024-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207922-003 DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL 2024-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207922-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL 2024-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207922-002 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL 2024-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207922-003 DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL 2024-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207922-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL 2024-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207922-002 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL 2024-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207922-003 DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL 2024-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207922-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2024-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207922-002 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2024-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207922-003 DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL AB 2024-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207922-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2024-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207922-002 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2024-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207922-003 DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL AB 2024-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207922-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2024-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207922-002 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2024-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207922-003 DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL AB 2024-12-19 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207922-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL 2024-12-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207922-002 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL 2024-12-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207922-003 DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL 2024-12-19 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207922-001 AB 1 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207922-002 AB 1 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207922-003 AB 1 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207922-001 AB 1 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207922-002 AB 1 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207922-003 AB 1 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207922-001 AB 1 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207922-002 AB 1 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207922-003 AB 1 03ed91905a0d…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.