Application 021692
- Type
- NDA
- Sponsor
- VALEANT PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ULTRAM ER | TRAMADOL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 100MG | Yes | No |
| 002 | ULTRAM ER | TRAMADOL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 200MG | Yes | No |
| 003 | ULTRAM ER | TRAMADOL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 300MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021692-001 | ULTRAM ER | TRAMADOL HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | |
| N021692-002 | ULTRAM ER | TRAMADOL HYDROCHLORIDE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | |
| N021692-003 | ULTRAM ER | TRAMADOL HYDROCHLORIDE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 |
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| 2026-08 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021692-003 | ULTRAM ER | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 301d65b070ca… |
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 | Proficient Rx LP | 00b7f61b-5173-43e6-a3f9-d2efbda40c19 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | 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 | Proficient Rx LP | 3c187736-ea96-4e59-9fe6-cb625a619c63 | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | 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 | Proficient Rx LP | 68646295-49b2-45ac-bf19-99bb91f7333d | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 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 | Amneal Pharmaceuticals LLC | 58b802cb-2443-4f5b-9718-7d54c6d50cb4 | 2021-10-30 | Boxed warning, Warnings, Adverse reactions | 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 | Proficient Rx LP | 50f4b752-20af-4ebf-9408-e78f30d2a3cc | 2019-11-01 | Warnings, Adverse reactions | 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 |
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 |
|---|---|---|---|---|---|
| 10147-0901 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Patriot Pharmaceuticals, LLC | NDA AUTHORIZED GENERIC | Current |
| 10147-0902 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Patriot Pharmaceuticals, LLC | NDA AUTHORIZED GENERIC | Current |
| 10147-0903 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Patriot Pharmaceuticals, LLC | NDA AUTHORIZED GENERIC | Current |
| 21695-292 | ULTRAM ER | tramadol hydrochloride | Rebel Distributors Corp | NDA | Current |
| 21695-563 | ULTRAM ER | tramadol hydrochloride | Rebel Distributors Corp | NDA | Current |
| 21695-913 | ULTRAM ER | tramadol hydrochloride | Rebel Distributors Corp | NDA | Current |
| 50458-653 | Ultram ER | Tramadol Hydrochloride | Janssen Pharmaceuticals, | NDA | Current |
| 50458-655 | Ultram ER | Tramadol Hydrochloride | Janssen Pharmaceuticals, | NDA | Current |
| 50458-657 | Ultram ER | Tramadol Hydrochloride | Janssen Pharmaceuticals, | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 49628 | SUPPL | 2017-08-30 |
| 49600 | SUPPL | 2017-08-30 |
| 49599 | SUPPL | 2017-08-30 |
| 46351 | SUPPL | 2016-12-21 |
| 46350 | SUPPL | 2016-12-21 |
| 46292 | SUPPL | 2016-12-20 |
| 46291 | SUPPL | 2016-12-20 |
| 5999 | SUPPL | 2009-03-19 |
| 37471 | SUPPL | 2008-02-25 |
| 15999 | SUPPL | 2008-02-25 |
| 28391 | SUPPL | 2008-02-22 |
| 28390 | SUPPL | 2008-02-22 |
| 5998 | SUPPL | 2006-08-07 |
| 15998 | SUPPL | 2006-08-04 |
| 42273 | ORIG | 2006-07-25 |
| 5997 | SUPPL | 2006-06-06 |
| 15997 | ORIG | 2005-09-09 |
| 5996 | ORIG | 2005-09-09 |