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| N011011-004 | ROBAXIN | METHOCARBAMOL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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N011011-006 | ROBAXIN-750 | METHOCARBAMOL | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |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| 2026-08 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||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| 2026-08 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||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| 2026-07 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||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| 2026-07 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||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 | GENTEX PHARMA, LLC | 35c044a6-90c0-55f8-e063-6294a90aad48 | 2025-05-22 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Preferred Pharmaceuticals Inc. | 9169399e-bca1-4c44-9a93-886f3650e44d | 2025-05-19 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol Tablets, USP, 750 mg | METHOCARBAMOL | Bryant Ranch Prepack | 3d686023-a4a2-4dae-8bfb-1f6b01ca24f0 | 2025-05-05 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Preferred Pharmaceuticals Inc. | 38d8b457-0c0f-45cb-bf90-965c5a01b198 | 2025-04-23 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Somerset Therapeutics, LLC | 68dd9c24-4d41-48be-9f54-fceb787bb443 | 2025-03-22 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Trifluent Pharma LLC | de2e3af9-03ab-4dc8-b480-6866474ad1bd | 2025-03-03 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Preferred Pharmaceuticals Inc. | eed9ebd1-c243-4e82-bf4e-5fec370e722e | 2025-02-10 | Warnings, Adverse reactions | METHOCARBAMOL |
| methocarbamol | METHOCARBAMOL | FH2 PHARMA LLC | 1dd56e3d-7ca7-1443-e063-6294a90a13c5 | 2025-02-06 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Coupler LLC | 2cee3893-70b7-6c2c-e063-6394a90aa79a | 2025-01-30 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Advanced Rx of Tennessee, LLC | 2cf76cdc-820d-1c5b-e063-6294a90a35aa | 2025-01-30 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Redpharm Drug, Inc. | 09d22ef9-a472-4db9-e063-6394a90a8870 | 2025-01-23 | Warnings, Adverse reactions | METHOCARBAMOL |
| METHOCARBAMOL | METHOCARBAMOL | DirectRx | ceb428e0-d6e4-57b7-e053-2995a90afcda | 2025-01-20 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Advanced Rx of Tennessee, LLC | afc9d84d-c8dd-05c0-e053-2a95a90a22a2 | 2024-12-31 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Advanced Rx of Tennessee, LLC | af73ae4b-bcf5-2e21-e053-2a95a90a2dce | 2024-12-31 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Advanced Rx Pharmacy of Tennessee, LLC | c06c4a63-491c-baa2-e053-2a95a90a09ff | 2024-12-31 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Advanced Rx Pharmacy of Tennessee, LLC | c9600cc9-7e27-6e19-e053-2995a90ab024 | 2024-12-31 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Advanced Rx Pharmacy of Tennessee, LLC | f4e98f9f-b20b-8608-e053-2a95a90aa6b0 | 2024-12-31 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Advanced Rx Pharmacy of Tennessee, LLC | f6567e04-12f0-fa79-e053-2995a90a9a0e | 2024-12-31 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Bryant Ranch Prepack | 8c18ffef-b2c5-4af2-af66-e22c168e7680 | 2024-12-24 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Key Therapeutics | a88a6c84-b55a-4b6b-ac01-554079f6e304 | 2024-10-09 | 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 |