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| N011011-004 | ROBAXIN | METHOCARBAMOL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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N011011-006 | ROBAXIN-750 | METHOCARBAMOL | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 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| 2026-07 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||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| 2026-07 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||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UTC | 2026-02 | N011011-004 | ROBAXIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||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UTC | 2026-02 | N011011-006 | ROBAXIN-750 | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||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… | |
| 2022-03-09 01:35 UTC | 2022-03 | 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 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | 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 | bb7c543d1eb4… |
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 | St. Mary's Medical Park Pharmacy | 56090def-7caf-e916-e063-6294a90a6ac2 | 2026-08-05 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Coupler LLC | 5827d07b-a0a4-a543-e063-6294a90ad565 | 2026-08-03 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | American Health Packaging | d842fe4e-fc46-4d70-9ca3-b47191672f96 | 2026-07-30 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Medcore LLC | 1a6b7327-fd42-4de0-bd0d-2dd478502d52 | 2026-07-29 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | PD-Rx Pharmaceuticals, Inc. | 3d4a2486-863e-4e9f-be3b-67882863e7d4 | 2026-07-29 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | PD-Rx Pharmaceuticals, Inc. | 6b9ed3a4-46d5-462e-ac93-6b959b314d77 | 2026-07-29 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | PD-Rx Pharmaceuticals, Inc. | adb49cb7-8900-44dc-add0-22e2cd8235ac | 2026-07-29 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | PD-Rx Pharmaceuticals, Inc. | 0deb5368-ffdc-40fc-a97c-ba89b7a97e50 | 2026-07-21 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Unit Dose Solutions, Inc. | 5539d4f6-1192-2770-e063-6394a90a1e50 | 2026-06-27 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | A-S Medication Solutions | 9617e2b0-4255-4542-95ca-9ee1818ca450 | 2026-06-26 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | HAWAII REPACK, INC. | 8643032a-c491-4ae4-ac46-5e0c4c79dc5b | 2026-06-26 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | A-S Medication Solutions | cfdc0d68-00ad-44d6-b932-819cc3d5d60e | 2026-06-26 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | A-S Medication Solutions | b81a8e64-ae41-409b-94a6-b36cb50bc25d | 2026-06-26 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | HAWAII REPACK, INC. | c4744824-4c74-411d-aa8e-c63ee9d89913 | 2026-06-25 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Preferred Pharmaceuticals Inc. | 4ef1c2c0-31e1-4f85-b645-ff47a057a994 | 2026-06-23 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Preferred Pharmaceuticals, Inc | 425abc3b-2111-4fac-bf27-b685d1e657af | 2026-06-23 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Direct_rx | 4c5c8933-a4b5-f9c2-e063-6294a90a6f00 | 2026-06-16 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Bryant Ranch Prepack | 5af36a83-2b36-4fe2-8c6a-61b551621421 | 2026-06-16 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Bryant Ranch Prepack | cc004f5c-d5fc-48c5-9f37-c59b9c37e113 | 2026-06-16 | Warnings, Adverse reactions | METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Bryant Ranch Prepack | 9076b4ad-17be-4933-a975-7bf80cc92b49 | 2026-06-10 | Warnings, Adverse reactions | METHOCARBAMOL |
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 |