Application 209404
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 002 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 200MG | No | No |
| 003 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 300MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209404-001 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | |
| A209404-002 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | |
| A209404-003 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209404-001 | AB1 |
| A209404-002 | AB1 |
| A209404-003 | AB1 |
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 | A209404-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209404-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209404-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209404-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209404-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209404-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209404-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209404-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209404-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209404-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209404-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209404-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209404-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209404-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209404-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | b8a1b40f171c… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209404-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209404-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209404-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2025-01-31 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209404-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209404-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209404-003 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209404-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209404-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209404-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209404-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209404-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209404-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209404-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209404-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209404-003 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209404-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209404-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209404-003 | AB1 | 1 | b8a1b40f171c… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209404-001 | AB1 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209404-002 | AB1 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209404-003 | AB1 | 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 |
|---|---|---|---|---|---|---|
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | aefc85bc-0820-4aee-8d94-313c5f1658f5 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 209404 ANDA209404 |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Macleods Pharmaceuticals Limited | a07ed444-54e4-4d45-b6a1-6ea2f6dedc61 | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | 209404 ANDA209404 |