Application 200503
- Type
- ANDA
- Sponsor
- LUPIN LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | Yes |
| 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 |
|---|---|---|---|---|---|---|---|
| A200503-001 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 |
| A200503-002 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | |
| A200503-003 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A200503-001 | AB1 |
| A200503-002 | AB1 |
| A200503-003 | 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 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-08-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2011-08-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2011-08-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-08-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2011-08-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2011-08-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A200503-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200503-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200503-003 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200503-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200503-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200503-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A200503-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200503-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200503-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200503-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200503-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200503-003 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200503-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200503-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200503-003 | AB1 | 1 | b8a1b40f171c… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200503-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200503-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200503-003 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200503-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200503-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200503-003 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A200503-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200503-002 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200503-003 | AB1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200503-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200503-002 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200503-003 | AB1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200503-001 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200503-002 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200503-003 | AB1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200503-001 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200503-002 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200503-003 | AB1 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A200503-001 | AB1 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A200503-002 | AB1 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A200503-003 | AB1 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200503-001 | AB1 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200503-002 | AB1 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200503-003 | AB1 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A200503-001 | AB1 | 1 | 5d02ea3f76ae… |
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 | REMEDYREPACK INC. | 16053b28-c759-4914-93e6-2de0afe72445 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 70518-0942 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | 6bb5be12-59ff-40f4-9841-9c7ab93be2ea | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 70518-0886 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | acd5d8e0-a4cc-4654-ae04-faff347a60ca | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | b76c1366-f6c0-42ad-bb19-2b72a91490e4 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 70518-2795 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | 46bb9ae6-3ee8-463c-badb-c7a45a89b84b | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 68180-697 68180-699 68180-698 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | 83367367-5654-4078-831a-69ade48bc795 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 68788-7601 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | c30f6e9e-8014-40fc-9615-a6b8654137c1 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | A-S Medication Solutions | c28c98ac-7e07-46a5-8f34-57c008308fba | 2025-09-05 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 50090-5107 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Coupler LLC | 2f23ba6c-89d2-cc42-e063-6394a90aee0a | 2025-02-27 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| Tramadol HCL ER | TRAMADOL HCL ER | Direct_Rx | 09a7af47-423a-1e8b-e063-6394a90a99ef | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | DIRECT RX | b3c702f7-0a8c-a52b-e053-2995a90a6df3 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 72189-154 |
| Tramadol HCL ER | TRAMADOL HCL | Advanced Rx Pharmacy of Tennessee, LLC | bf51a3af-cbc6-3021-e053-2a95a90a80b7 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 80425-0136 |
| Tramadol HCL ER | TRAMADOL HCL | Advanced Rx Pharmacy of Tennessee, LLC | f8c5328d-7b47-626e-e053-6294a90a04b3 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Quality Care Products, LLC | 68484531-f908-473f-a422-f37234de9691 | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Quality Care Products, LLC | 7e421fb6-737c-49b3-b299-50511e281a4d | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| Tramadol HCL ER | TRAMADOL HCL | Advanced Rx Pharmacy of Tennessee, LLC | b4cd4b64-7db5-da44-e053-2995a90a8953 | 2024-11-20 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 80425-0108 |
| TRAMADOL HCL ER | TRAMADOL HCL | DIRECT RX | 5285f056-c32c-4e7a-bec6-3a726aa23d5a | 2024-10-17 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 61919-818 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 8cc09b31-6067-44ec-8aba-ea7bb1a1f448 | 2024-08-28 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 63629-8323 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | b2f3f007-6dda-4532-9f7f-d93f6e65254c | 2024-08-28 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 63629-8319 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 93c9c960-afbf-6d3d-e053-2995a90a8d15 | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 68071-1671 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45865-969 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | medsource pharmaceuticals | ANDA | Current |
| 45865-976 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | medsource pharmaceuticals | ANDA | Current |
| 50090-5106 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-5107 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50436-0698 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Unit Dose Services | ANDA | Current |
| 61919-818 | TRAMADOL HCL | TRAMADOL HCL | DIRECT RX | ANDA | Current |
| 61919-818 | TRAMADOL HCL | TRAMADOL HCL | DIRECT RX | ANDA | Current |
| 61919-818 | TRAMADOL HCL | TRAMADOL HCL | DIRECT RX | ANDA | Current |
| 61919-818 | TRAMADOL HCL | TRAMADOL HCL | DIRECT RX | ANDA | Current |
| 61919-818 | TRAMADOL HCL | TRAMADOL HCL | DIRECT RX | ANDA | Current |
| 63629-8319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-8319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-8323 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-8323 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 68071-1671 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1671 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2329 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2410 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5078 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5078 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5261 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5261 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68180-697 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-697 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-697 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-697 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-697 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-697 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-697 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-698 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-698 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-698 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-698 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-698 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-698 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-698 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-699 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-699 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-699 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-699 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-699 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-699 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-699 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7601 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7601 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7601 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7601 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7609 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0886 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0886 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0886 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0886 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0886 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0886 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0886 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0942 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0942 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0942 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0942 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0942 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0942 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2795 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2795 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2795 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2795 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 71205-463 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71205-463 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71205-468 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71205-468 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71205-569 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71205-569 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 72189-154 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 80425-0108 | Ultram | Tramadol HCl 100mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0108 | Tramadol HCL | Tramadol HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0108 | Tramadol HCL | Tramadol HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0108 | Tramadol HCL | Tramadol HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0136 | Conzip | Tramadol HCl 200mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0136 | Tramadol HCL | Tramadol HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0136 | Tramadol HCL | Tramadol HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0136 | Tramadol HCL | Tramadol HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76104 | ORIG | 2023-11-02 |