Application 215233
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215233-001 | DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | |
| A215233-002 | DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | |
| A215233-003 | DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 110MG BASE | CAPSULE / ORAL | AB | 2024-08-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A215233-001 | AB |
| A215233-002 | AB |
| A215233-003 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A215233-001 | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215233-002 | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215233-003 | DABIGATRAN ETEXILATE MESYLATE | EQ 110MG BASE | CAPSULE / ORAL | AB | 2024-08-12 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215233-001 | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215233-002 | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215233-003 | DABIGATRAN ETEXILATE MESYLATE | EQ 110MG BASE | CAPSULE / ORAL | AB | 2024-08-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215233-001 | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215233-002 | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215233-003 | DABIGATRAN ETEXILATE MESYLATE | EQ 110MG BASE | CAPSULE / ORAL | AB | 2024-08-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215233-001 | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215233-002 | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215233-003 | DABIGATRAN ETEXILATE MESYLATE | EQ 110MG BASE | CAPSULE / ORAL | AB | 2024-08-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215233-001 | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215233-002 | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215233-003 | DABIGATRAN ETEXILATE MESYLATE | EQ 110MG BASE | CAPSULE / ORAL | AB | 2024-08-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215233-001 | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215233-002 | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215233-003 | DABIGATRAN ETEXILATE MESYLATE | EQ 110MG BASE | CAPSULE / ORAL | AB | 2024-08-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215233-001 | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215233-002 | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215233-003 | DABIGATRAN ETEXILATE MESYLATE | EQ 110MG BASE | CAPSULE / ORAL | AB | 2024-08-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215233-001 | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215233-002 | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215233-003 | DABIGATRAN ETEXILATE MESYLATE | EQ 110MG BASE | CAPSULE / ORAL | AB | 2024-08-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215233-001 | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215233-002 | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215233-003 | DABIGATRAN ETEXILATE MESYLATE | EQ 110MG BASE | CAPSULE / ORAL | AB | 2024-08-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215233-001 | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215233-002 | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215233-003 | DABIGATRAN ETEXILATE MESYLATE | EQ 110MG BASE | CAPSULE / ORAL | AB | 2024-08-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A215233-001 | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A215233-002 | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A215233-003 | DABIGATRAN ETEXILATE MESYLATE | EQ 110MG BASE | CAPSULE / ORAL | AB | 2024-08-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215233-001 | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215233-002 | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215233-001 | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215233-002 | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | 301d65b070ca… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215233-001 | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215233-002 | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2024-06-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215233-003 | DABIGATRAN ETEXILATE MESYLATE | EQ 110MG BASE | CAPSULE / ORAL | AB | 2024-08-12 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A215233-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A215233-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A215233-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A215233-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215233-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215233-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215233-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215233-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215233-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A215233-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215233-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215233-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215233-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215233-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215233-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215233-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215233-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215233-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215233-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215233-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215233-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215233-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215233-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215233-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215233-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215233-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215233-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215233-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215233-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215233-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A215233-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A215233-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A215233-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215233-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215233-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215233-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215233-002 | AB | 1 | 301d65b070ca… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215233-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215233-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215233-003 | AB | 1 | a50c72e98297… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dabigatran Etexilate | DABIGATRAN ETEXILATE | Alembic Pharmaceuticals Limited | 13649035-a498-4e31-a7ea-8b18cedceca7 | 2025-11-20 | Boxed warning, Warnings, Adverse reactions | 215233 ANDA215233 |
| Dabigatran Etexilate | DABIGATRAN ETEXILATE | Alembic Pharmaceuticals Inc. | 834a3c5f-b723-4bcb-a560-dc305dd0d829 | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | 215233 ANDA215233 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79392 | ORIG | 2024-08-14 |