Application 214358
- Type
- NDA
- Sponsor
- BOEHRINGER INGELHEIM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRADAXA | DABIGATRAN | PELLETS;ORAL | 20MG | No | No |
| 002 | PRADAXA | DABIGATRAN | PELLETS;ORAL | 30MG | No | No |
| 003 | PRADAXA | DABIGATRAN | PELLETS;ORAL | 40MG | No | No |
| 004 | PRADAXA | DABIGATRAN | PELLETS;ORAL | 50MG | No | No |
| 005 | PRADAXA | DABIGATRAN | PELLETS;ORAL | 110MG | No | No |
| 006 | PRADAXA | DABIGATRAN | PELLETS;ORAL | 150MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N214358-001 | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | EQ 20MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | |
| N214358-002 | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | EQ 30MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | |
| N214358-003 | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | EQ 40MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | |
| N214358-004 | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | EQ 50MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | |
| N214358-005 | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | EQ 110MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | |
| N214358-006 | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE/PACKET | PELLETS / ORAL | RLD, RS | 2021-06-21 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N214358-001 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | |
| N214358-001 | 7932273*PED | 2026-03-07 | Pediatric extension | ||
| N214358-002 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | |
| N214358-002 | 7932273*PED | 2026-03-07 | Pediatric extension | ||
| N214358-003 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | |
| N214358-003 | 7932273*PED | 2026-03-07 | Pediatric extension | ||
| N214358-004 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | |
| N214358-004 | 7932273*PED | 2026-03-07 | Pediatric extension | ||
| N214358-005 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | |
| N214358-005 | 7932273*PED | 2026-03-07 | Pediatric extension | ||
| N214358-006 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | |
| N214358-006 | 7932273*PED | 2026-03-07 | Pediatric extension |
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 | 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 | N214358-001 | PRADAXA | EQ 20MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214358-002 | PRADAXA | EQ 30MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214358-003 | PRADAXA | EQ 40MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214358-004 | PRADAXA | EQ 50MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214358-005 | PRADAXA | EQ 110MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214358-006 | PRADAXA | EQ 150MG BASE/PACKET | PELLETS / ORAL | RLD, RS | 2021-06-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214358-001 | PRADAXA | EQ 20MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214358-002 | PRADAXA | EQ 30MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214358-003 | PRADAXA | EQ 40MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214358-004 | PRADAXA | EQ 50MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214358-005 | PRADAXA | EQ 110MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214358-006 | PRADAXA | EQ 150MG BASE/PACKET | PELLETS / ORAL | RLD, RS | 2021-06-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214358-001 | PRADAXA | EQ 20MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214358-002 | PRADAXA | EQ 30MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214358-003 | PRADAXA | EQ 40MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214358-004 | PRADAXA | EQ 50MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214358-005 | PRADAXA | EQ 110MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214358-006 | PRADAXA | EQ 150MG BASE/PACKET | PELLETS / ORAL | RLD, RS | 2021-06-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214358-001 | PRADAXA | EQ 20MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214358-002 | PRADAXA | EQ 30MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214358-003 | PRADAXA | EQ 40MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214358-004 | PRADAXA | EQ 50MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214358-005 | PRADAXA | EQ 110MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214358-006 | PRADAXA | EQ 150MG BASE/PACKET | PELLETS / ORAL | RLD, RS | 2021-06-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214358-001 | PRADAXA | EQ 20MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214358-002 | PRADAXA | EQ 30MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214358-003 | PRADAXA | EQ 40MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214358-004 | PRADAXA | EQ 50MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214358-005 | PRADAXA | EQ 110MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214358-006 | PRADAXA | EQ 150MG BASE/PACKET | PELLETS / ORAL | RLD, RS | 2021-06-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214358-001 | PRADAXA | EQ 20MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214358-002 | PRADAXA | EQ 30MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214358-003 | PRADAXA | EQ 40MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214358-004 | PRADAXA | EQ 50MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214358-005 | PRADAXA | EQ 110MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214358-006 | PRADAXA | EQ 150MG BASE/PACKET | PELLETS / ORAL | RLD, RS | 2021-06-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214358-001 | PRADAXA | EQ 20MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214358-002 | PRADAXA | EQ 30MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214358-003 | PRADAXA | EQ 40MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214358-004 | PRADAXA | EQ 50MG BASE/PACKET | PELLETS / ORAL | RLD | 2021-06-21 | 2680178bc6a6… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N214358-001 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214358-001 | 7932273*PED | 2026-03-07 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N214358-002 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214358-002 | 7932273*PED | 2026-03-07 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N214358-003 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214358-003 | 7932273*PED | 2026-03-07 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N214358-004 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214358-004 | 7932273*PED | 2026-03-07 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N214358-005 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214358-005 | 7932273*PED | 2026-03-07 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N214358-006 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214358-006 | 7932273*PED | 2026-03-07 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214358-001 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214358-001 | 7932273*PED | 2026-03-07 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214358-002 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214358-002 | 7932273*PED | 2026-03-07 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214358-003 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214358-003 | 7932273*PED | 2026-03-07 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214358-004 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214358-004 | 7932273*PED | 2026-03-07 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214358-005 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214358-005 | 7932273*PED | 2026-03-07 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214358-006 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214358-006 | 7932273*PED | 2026-03-07 | Pediatric extension | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N214358-001 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214358-001 | 7932273*PED | 2026-03-07 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N214358-002 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214358-002 | 7932273*PED | 2026-03-07 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N214358-003 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214358-003 | 7932273*PED | 2026-03-07 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N214358-004 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214358-004 | 7932273*PED | 2026-03-07 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N214358-005 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214358-005 | 7932273*PED | 2026-03-07 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N214358-006 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214358-006 | 7932273*PED | 2026-03-07 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214358-001 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214358-001 | 7932273*PED | 2026-03-07 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214358-002 | 7932273 | 2025-09-07 | Drug substance, Drug product | 2021-07-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214358-002 | 7932273*PED | 2026-03-07 | Pediatric extension | fd3edfee7708… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214358-001 | NP | 2024-06-21 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214358-001 | PED | 2024-12-21 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214358-002 | NP | 2024-06-21 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214358-002 | PED | 2024-12-21 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214358-003 | NP | 2024-06-21 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214358-003 | PED | 2024-12-21 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214358-004 | NP | 2024-06-21 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214358-004 | PED | 2024-12-21 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214358-005 | NP | 2024-06-21 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214358-005 | PED | 2024-12-21 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214358-006 | NP | 2024-06-21 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214358-006 | PED | 2024-12-21 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214358-001 | NP | 2024-06-21 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214358-001 | PED | 2024-12-21 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214358-002 | NP | 2024-06-21 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214358-002 | PED | 2024-12-21 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214358-003 | NP | 2024-06-21 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214358-003 | PED | 2024-12-21 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214358-004 | NP | 2024-06-21 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214358-004 | PED | 2024-12-21 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214358-005 | NP | 2024-06-21 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214358-005 | PED | 2024-12-21 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214358-006 | NP | 2024-06-21 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214358-006 | PED | 2024-12-21 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214358-001 | NP | 2024-06-21 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214358-001 | PED | 2024-12-21 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214358-002 | NP | 2024-06-21 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214358-002 | PED | 2024-12-21 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214358-003 | NP | 2024-06-21 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214358-003 | PED | 2024-12-21 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214358-004 | NP | 2024-06-21 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214358-004 | PED | 2024-12-21 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214358-005 | NP | 2024-06-21 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214358-005 | PED | 2024-12-21 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214358-006 | NP | 2024-06-21 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214358-006 | PED | 2024-12-21 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214358-001 | NP | 2024-06-21 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214358-001 | PED | 2024-12-21 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214358-002 | NP | 2024-06-21 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214358-002 | PED | 2024-12-21 | d8e5a09893c0… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pradaxa | DABIGATRAN ETEXILATE | Boehringer Ingelheim Pharmaceuticals, Inc. | 9ac0a64a-8666-45f7-9d4f-40fd894f7e6d | 2025-06-27 | Boxed warning, Warnings, Adverse reactions | 214358 NDA214358 0597-0430 0597-0435 0597-0425 0597-0445 0597-0450 0597-0440 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0597-0425 | Pradaxa | DABIGATRAN ETEXILATE MESYLATE | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0425 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0425 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0430 | Pradaxa | DABIGATRAN ETEXILATE MESYLATE | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0430 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0430 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0435 | Pradaxa | DABIGATRAN ETEXILATE MESYLATE | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0435 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0435 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0440 | Pradaxa | DABIGATRAN ETEXILATE MESYLATE | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0440 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0440 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0445 | Pradaxa | DABIGATRAN ETEXILATE MESYLATE | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0445 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0445 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0450 | Pradaxa | DABIGATRAN ETEXILATE MESYLATE | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0450 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0450 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83643 | SUPPL | 2025-10-03 |
| 82604 | SUPPL | 2025-10-03 |
| 82605 | SUPPL | 2025-06-20 |
| 76575 | SUPPL | 2023-11-15 |
| 76570 | SUPPL | 2023-11-15 |
| 70698 | SUPPL | 2022-04-05 |
| 70697 | SUPPL | 2022-04-05 |
| 70678 | ORIG | 2022-04-01 |
| 70630 | SUPPL | 2022-03-28 |
| 67871 | ORIG | 2021-06-23 |
| 67847 | ORIG | 2021-06-22 |
| 67846 | ORIG | 2021-06-22 |