Application 011011
- Type
- NDA
- Sponsor
- AUXILIUM PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 004 | ROBAXIN | METHOCARBAMOL | TABLET;ORAL | 500MG | Yes | No |
| 006 | ROBAXIN-750 | METHOCARBAMOL | TABLET;ORAL | 750MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N011011-004 | ROBAXIN | METHOCARBAMOL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011011-006 | ROBAXIN-750 | METHOCARBAMOL | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |
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| 2026-08 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N011011-004 | ROBAXIN | 500MG | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N011011-006 | ROBAXIN-750 | 750MG | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N011011-004 | ROBAXIN | 500MG | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N011011-006 | ROBAXIN-750 | 750MG | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N011011-004 | ROBAXIN | 500MG | TABLET / ORAL | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N011011-006 | ROBAXIN-750 | 750MG | TABLET / ORAL | AA | RLD, RS, Approved before 1982 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N011011-006 | AA | 1 | 74a2ff9319b5… |
| 2020-11-12 02:37 UTC | 2020-11 | N011011-006 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N011011-006 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N011011-006 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N011011-004 | AA | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N011011-006 | AA | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Methocarbamol | METHOCARBAMOL | PHOENIX RX LLC | 39bc9ecf-837e-5bb8-e063-6394a90a917e | 2025-11-13 | Warnings, Adverse reactions | METHOCARBAMOL |
| METHOCARBAMOL | METHOCARBAMOL | Henry Schein, Inc | d48d76af-b55a-4908-95ff-e7de615c0513 | 2025-10-31 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | A-S Medication Solutions | 9aed8304-fa4e-49d6-bd81-fcb3e4cc6173 | 2025-10-16 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | A-S Medication Solutions | ff55df39-e314-4120-8fab-3757cbe5a872 | 2025-10-16 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | A-S Medication Solutions | 069045f1-d699-41d0-b674-cdb71cd5fbd0 | 2025-10-15 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Bryant Ranch Prepack | f7ab7f11-9b5a-4d3a-a8fc-eee55b1fc006 | 2025-10-13 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Bryant Ranch Prepack | fdea0332-1ad8-40ef-8cb9-b3c46588155d | 2025-10-13 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Sagent Pharmaceuticals | 01e7e2c7-49eb-4afb-a496-f2bd901622e9 | 2025-09-29 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Solco Healthcare LLC | 32863f21-30ff-4a8b-a2e6-8ab14a37af0d | 2025-09-25 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol Tablets, USP, 500 mg | METHOCARBAMOL | PD-Rx Pharmaceuticals, Inc. | 6ca768bf-5095-4148-82d2-a0c2dec16d87 | 2025-09-16 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol Tablets, USP, 500 mg | METHOCARBAMOL | Bryant Ranch Prepack | dfb0e2ee-fd87-4100-9d44-f7a091e73a6c | 2025-09-12 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Doc Rx | 5e55526f-bb34-4b67-85ea-b2765e8066bb | 2025-09-04 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | PHOENIX RX LLC | 3b199152-bafc-e14a-e063-6394a90ab283 | 2025-07-29 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | A-S Medication Solutions | ff572473-90e3-4f3b-a40e-8b97b86d327b | 2025-07-16 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol Tablets, USP, 500 mg | METHOCARBAMOL | PD-Rx Pharmaceuticals, Inc. | 6500c6eb-fa1e-46a5-839f-13047e107e97 | 2025-07-08 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol Tablets, USP, 500 mg | METHOCARBAMOL | Granulation Technology, Inc. | 70c5342c-9597-4fe6-863c-f8ae4adc063a | 2025-06-10 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Golden State Medical Supply, Inc. | c67d3e2b-92cd-1b97-e053-2a95a90af36f | 2025-06-10 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | A-S Medication Solutions | 9357672f-5d4d-40f5-a304-e0c34e174dc3 | 2025-06-09 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Bryant Ranch Prepack | 43ea5baa-4200-47ff-8819-44c802cba977 | 2025-06-02 | Warnings, Adverse reactions | METHOCARBAMOL |
| METHOCARBAMOL | METHOCARBAMOL | Preferred Pharmaceuticals Inc. | 5a48be27-5069-40f3-85de-86f248ae232f | 2025-06-02 | Warnings, Adverse reactions | METHOCARBAMOL |
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 |
|---|---|---|---|---|---|
| 52244-429 | Robaxin | Methocarbamol | Endo Pharmaceuticals, Inc. | NDA | Current |
| 52244-449 | Robaxin | Methocarbamol | Endo Pharmaceuticals, Inc. | NDA | Current |
| 52244-449 | Robaxin | Methocarbamol | Endo Pharmaceuticals Inc. | NDA | Current |
| 52244-449 | Robaxin | Methocarbamol | Endo Pharmaceuticals, Inc. | NDA | Current |