Application 075964
- Type
- ANDA
- Sponsor
- SUN PHARM INDS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075964-001 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075964-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2002-06-19 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2002-06-19 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2002-06-19 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2002-06-19 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2002-06-19 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2002-06-19 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2002-06-19 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2002-06-19 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2002-06-19 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2002-06-19 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2002-06-19 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2002-06-19 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2002-06-19 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2002-06-19 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2002-06-19 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2002-06-19 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2002-06-19 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2002-06-19 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A075964-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2002-06-19 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075964-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A075964-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075964-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075964-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075964-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075964-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075964-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075964-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075964-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075964-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075964-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075964-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075964-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075964-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075964-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075964-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075964-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075964-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075964-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075964-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A075964-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A075964-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075964-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A075964-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A075964-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A075964-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A075964-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A075964-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A075964-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075964-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A075964-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A075964-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075964-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075964-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075964-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075964-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A075964-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A075964-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075964-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A075964-001 | AB | 1 | f41ea6bd6efb… |
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 | 0bff5535-0239-409e-8a2a-99d5ba38cca3 | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | 00b7f61b-5173-43e6-a3f9-d2efbda40c19 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Asclemed USA, Inc. | dce0d21e-e4c2-4875-a2ce-9d53df190b80 | 2022-07-25 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | 3c187736-ea96-4e59-9fe6-cb625a619c63 | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | 27495d02-8641-4c92-b5a3-edf50abc2a6f | 2022-05-02 | Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | 68646295-49b2-45ac-bf19-99bb91f7333d | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | f63facd7-519b-4e2b-b54f-c17fc9ede55f | 2022-03-01 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Amneal Pharmaceuticals LLC | 58b802cb-2443-4f5b-9718-7d54c6d50cb4 | 2021-10-30 | Boxed warning, Warnings, Adverse reactions | Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | TRUPHARMA LLC | 61fb5ba7-6896-4ee4-83de-caee69b06a8e | 2021-02-13 | Boxed warning, Warnings, Adverse reactions | Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | 50f4b752-20af-4ebf-9408-e78f30d2a3cc | 2019-11-01 | Warnings, Adverse reactions | Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | bbd6c0d4-110c-4bda-9d9f-89ab7ce4c18e | 2019-04-04 | Boxed warning, Warnings, Adverse reactions | Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-7179 | tramadol hydrochloride | tramadol hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 16714-481 | tramadol hydrochloride | tramadol hydrochloride | Northstar Rx LLC | ANDA | Current |
| 16714-481 | tramadol hydrochloride | tramadol hydrochloride | Northstar Rx LLC | ANDA | Current |
| 16714-481 | tramadol hydrochloride | tramadol hydrochloride | Northstar Rx LLC | ANDA | Current |
| 33261-483 | tramadol hydrochloride | tramadol hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 45865-115 | tramadol hydrochloride | tramadol hydrochloride | Medsource Pharmaceuticals | ANDA | Current |
| 45865-120 | tramadol hydrochloride | tramadol hydrochloride | Medsource Pharmaceuticals | ANDA | Current |
| 50090-0806 | tramadol hydrochloride | tramadol hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0806 | tramadol hydrochloride | tramadol hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0807 | tramadol hydrochloride | tramadol hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0807 | tramadol hydrochloride | tramadol hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3501 | tramadol hydrochloride | tramadol hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50436-0377 | tramadol hydrochloride | tramadol hydrochloride | Unit Dose Services | ANDA | Current |
| 53002-4322 | tramadol hydrochloride | tramadol hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-864 | tramadol hydrochloride | tramadol hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-864 | tramadol hydrochloride | tramadol hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-864 | tramadol hydrochloride | tramadol hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-864 | tramadol hydrochloride | tramadol hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 57664-377 | tramadol hydrochloride | tramadol hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-377 | tramadol hydrochloride | tramadol hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-377 | tramadol hydrochloride | tramadol hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-377 | tramadol hydrochloride | tramadol hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-377 | tramadol hydrochloride | tramadol hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-377 | tramadol hydrochloride | tramadol hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-377 | tramadol hydrochloride | tramadol hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 58118-0377 | tramadol hydrochloride | tramadol hydrochloride | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-0377 | tramadol hydrochloride | tramadol hydrochloride | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 60760-377 | tramadol hydrochloride | tramadol hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-377 | tramadol hydrochloride | tramadol hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-377 | tramadol hydrochloride | tramadol hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-377 | tramadol hydrochloride | tramadol hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-229 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 61919-229 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-229 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-229 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-229 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 61919-229 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-229 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-229 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 61919-229 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 61919-229 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 63629-4394 | tramadol hydrochloride | tramadol hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-4394 | tramadol hydrochloride | tramadol hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-4394 | tramadol hydrochloride | tramadol hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8190 | tramadol hydrochloride | tramadol hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8190 | tramadol hydrochloride | tramadol hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 66336-915 | tramadol hydrochloride | tramadol hydrochloride | Dispensing Solutions, Inc. | ANDA | Current |
| 67046-729 | tramadol hydrochloride | tramadol hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-1021 | tramadol hydrochloride | tramadol hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1021 | tramadol hydrochloride | tramadol hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1021 | tramadol hydrochloride | tramadol hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 68071-4282 | tramadol hydrochloride | tramadol hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4282 | tramadol hydrochloride | tramadol hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4282 | tramadol hydrochloride | tramadol hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4802 | tramadol hydrochloride | tramadol hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4802 | tramadol hydrochloride | tramadol hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4802 | tramadol hydrochloride | tramadol hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5142 | tramadol hydrochloride | tramadol hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5142 | tramadol hydrochloride | tramadol hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5142 | tramadol hydrochloride | tramadol hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5204 | tramadol hydrochloride | tramadol hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5204 | tramadol hydrochloride | tramadol hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5204 | tramadol hydrochloride | tramadol hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5204 | tramadol hydrochloride | tramadol hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5204 | tramadol hydrochloride | tramadol hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5204 | tramadol hydrochloride | tramadol hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7321 | tramadol hydrochloride | tramadol hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7321 | tramadol hydrochloride | tramadol hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7321 | tramadol hydrochloride | tramadol hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7321 | tramadol hydrochloride | tramadol hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0258 | tramadol hydrochloride | tramadol hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0258 | tramadol hydrochloride | tramadol hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0258 | tramadol hydrochloride | tramadol hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0258 | tramadol hydrochloride | tramadol hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0258 | tramadol hydrochloride | tramadol hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0258 | tramadol hydrochloride | tramadol hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0258 | tramadol hydrochloride | tramadol hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0258 | tramadol hydrochloride | tramadol hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0258 | tramadol hydrochloride | tramadol hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0891 | tramadol hydrochloride | tramadol hydrochloride | REMEDYREPACK INC. | ANDA | Current |