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| ULTRAM ER | TRAMADOL HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | |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| ULTRAM ER | TRAMADOL HYDROCHLORIDE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | |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| ULTRAM ER | TRAMADOL HYDROCHLORIDE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 |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| 2026-08 | N021692-001 | ULTRAM ER | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 84e616aacf4f… | |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| 2026-08 | N021692-002 | ULTRAM ER | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2005-09-08 | 84e616aacf4f… | |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 | Cranbury Pharmaceuticals, LLC | 1d4af58f-17f3-4cbd-870c-098ace954872 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f4ea18b0-2cbd-0d42-e053-2995a90a9264 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Quality Care Products, LLC | f79fda81-f09a-4a08-babc-6bd3bb3ee661 | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Quality Care Products, LLC | 68484531-f908-473f-a422-f37234de9691 | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Quality Care Products, LLC | 7e421fb6-737c-49b3-b299-50511e281a4d | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 27460cc6-0782-7838-e063-6394a90a19f1 | 2024-11-18 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| tramadol hydrochloride | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 6ebc5864-c222-4400-a9b2-f66fd6fb0da6 | 2024-11-04 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HCL ER | TRAMADOL HCL | DIRECT RX | 5285f056-c32c-4e7a-bec6-3a726aa23d5a | 2024-10-17 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| tramadol hydrochloride | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 1cd3caee-bf54-7aba-e063-6394a90ad8cb | 2024-10-04 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f44c53ec-26ea-d272-e053-2a95a90a5e59 | 2024-09-09 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 8cc09b31-6067-44ec-8aba-ea7bb1a1f448 | 2024-08-28 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | b2f3f007-6dda-4532-9f7f-d93f6e65254c | 2024-08-28 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 93c9c960-afbf-6d3d-e053-2995a90a8d15 | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| tramadol hydrochloride | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | 2236031d-8596-4c21-8b16-83aa3e4122c1 | 2024-07-01 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 93e129c8-64c4-1f6d-e053-2a95a90ac1f8 | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | e90d4ef3-8b90-41b7-bf96-340852e89b5f | 2024-04-01 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Medsource Pharmaceuticals | 1278980b-4068-df57-e063-6394a90a8742 | 2024-02-28 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | 3e0ccb95-3e8e-477c-b4d2-6060ee05f930 | 2023-12-11 | Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Asclemed USA, Inc. | a26ca887-e26c-4c32-8dbd-1fa2eb6db9dc | 2023-02-15 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | TruPharma, LLC | aea56ff9-94ac-47a8-8f15-8790d538973b | 2023-01-25 | 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 |