Application 075968
- Type
- ANDA
- Sponsor
- FOSUN PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
| 002 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075968-001 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-25 | |
| A075968-002 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075968-001 | AB |
| A075968-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075968-002 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075968-002 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075968-002 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-02 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075968-002 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-02 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075968-002 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-02 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075968-002 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-02 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075968-002 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-02 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075968-002 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-02 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075968-002 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-02 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075968-002 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-02 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075968-002 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-02 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075968-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | 2002-06-25 | 1c564ffb4f44… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075968-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075968-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075968-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075968-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075968-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075968-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075968-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075968-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075968-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075968-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075968-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075968-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075968-002 | AB | 1 | 79d66fd596c7… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A075968-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A075968-002 | 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 |
|---|---|---|---|---|---|---|
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 42de8c3a-0441-5d46-e063-6294a90a2079 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 075968 ANDA075968 |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 552e5b32-accf-29dd-e063-6294a90a4fcf | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 075968 ANDA075968 |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 515baa9a-b226-4bbe-be87-f9befdf1c9e1 | 2026-06-18 | Boxed warning, Warnings, Adverse reactions | 075968 ANDA075968 |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 855905c7-1481-4b2d-a318-3254ad8ed73c | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | 075968 ANDA075968 |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Rising Pharma Holdings, Inc. | b5852b90-e415-47ef-8f73-87266b58e033 | 2026-03-11 | Boxed warning, Warnings, Adverse reactions | 075968 ANDA075968 |