Application 084616
- Type
- ANDA
- Sponsor
- FOSUN PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHOCARBAMOL | METHOCARBAMOL | TABLET;ORAL | 500MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A084616-001 | METHOCARBAMOL | METHOCARBAMOL | 500MG | TABLET / ORAL | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A084616-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | cb3db0bc1861… |
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 | American Health Packaging | d842fe4e-fc46-4d70-9ca3-b47191672f96 | 2026-07-30 | Warnings, Adverse reactions | Methocarbamol METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | Medcore LLC | 1a6b7327-fd42-4de0-bd0d-2dd478502d52 | 2026-07-29 | Warnings, Adverse reactions | Methocarbamol METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | PD-Rx Pharmaceuticals, Inc. | 3d4a2486-863e-4e9f-be3b-67882863e7d4 | 2026-07-29 | Warnings, Adverse reactions | Methocarbamol METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | PD-Rx Pharmaceuticals, Inc. | 6b9ed3a4-46d5-462e-ac93-6b959b314d77 | 2026-07-29 | Warnings, Adverse reactions | Methocarbamol METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | PD-Rx Pharmaceuticals, Inc. | adb49cb7-8900-44dc-add0-22e2cd8235ac | 2026-07-29 | Warnings, Adverse reactions | Methocarbamol METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | PD-Rx Pharmaceuticals, Inc. | 0deb5368-ffdc-40fc-a97c-ba89b7a97e50 | 2026-07-21 | Warnings, Adverse reactions | Methocarbamol METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL TABLETS | REMEDYREPACK INC. | 52b20439-6bf4-435e-817a-c3b3fc70846a | 2026-07-10 | Warnings, Adverse reactions | Methocarbamol |
| Methocarbamol | METHOCARBAMOL TABLETS | REMEDYREPACK INC. | 37767123-8b72-4e1f-b00d-ff3305e9923f | 2026-07-10 | Warnings, Adverse reactions | Methocarbamol |
| Methocarbamol | METHOCARBAMOL TABLETS | Unit Dose Solutions, Inc. | 561ae476-9e1f-038a-e063-6394a90aa5c7 | 2026-07-08 | Warnings, Adverse reactions | Methocarbamol |
| Methocarbamol | METHOCARBAMOL TABLETS | Granules Pharmaceuticals Inc. | 6f0d3966-962d-fa7c-e053-2a91aa0a8e3c | 2026-07-07 | Warnings, Adverse reactions | Methocarbamol |
| Methocarbamol | METHOCARBAMOL | St. Mary's Medical Park Pharmacy | 56090def-7caf-e916-e063-6294a90a6ac2 | 2026-07-07 | Warnings, Adverse reactions | Methocarbamol METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL TABLETS | Bryant Ranch Prepack | 65c460f6-6470-41ff-abb4-d9d54ecc52f7 | 2026-07-06 | Warnings, Adverse reactions | Methocarbamol |
| Methocarbamol | METHOCARBAMOL | Unit Dose Solutions, Inc. | 5539d4f6-1192-2770-e063-6394a90a1e50 | 2026-06-27 | Warnings, Adverse reactions | Methocarbamol METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | A-S Medication Solutions | 9617e2b0-4255-4542-95ca-9ee1818ca450 | 2026-06-26 | Warnings, Adverse reactions | Methocarbamol METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | HAWAII REPACK, INC. | 8643032a-c491-4ae4-ac46-5e0c4c79dc5b | 2026-06-26 | Warnings, Adverse reactions | Methocarbamol METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL TABLETS | St. Mary's Medical Park Pharmacy | 7d4dd78a-f902-6ff2-e053-2991aa0ac7d7 | 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 | METHOCARBAMOL | A-S Medication Solutions | b81a8e64-ae41-409b-94a6-b36cb50bc25d | 2026-06-26 | Warnings, Adverse reactions | Methocarbamol METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL | HAWAII REPACK, INC. | c4744824-4c74-411d-aa8e-c63ee9d89913 | 2026-06-25 | Warnings, Adverse reactions | Methocarbamol METHOCARBAMOL |
| Methocarbamol | METHOCARBAMOL TABLETS | Preferred Pharmaceuticals Inc. | 43f83b87-e169-46fe-98bd-6af373595bd3 | 2026-06-23 | Warnings, Adverse reactions | Methocarbamol |