Application 213967
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHOCARBAMOL | METHOCARBAMOL | TABLET;ORAL | 750MG | No | No |
| 002 | 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 |
|---|---|---|---|---|---|---|---|
| A213967-001 | METHOCARBAMOL | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2020-08-12 | |
| A213967-002 | METHOCARBAMOL | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2023-02-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213967-001 | AA |
| A213967-002 | AA |
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 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2020-08-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213967-002 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2023-02-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2020-08-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213967-002 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2023-02-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2020-08-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213967-002 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2023-02-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2020-08-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213967-002 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2023-02-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2020-08-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213967-002 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2023-02-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2020-08-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213967-002 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2023-02-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2020-08-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213967-002 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2023-02-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2020-08-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213967-002 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2023-02-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2020-08-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213967-002 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2023-02-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2020-08-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213967-002 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2023-02-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2020-08-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213967-002 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2023-02-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2020-08-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213967-002 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2023-02-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2020-08-12 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213967-002 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2023-02-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2020-08-12 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213967-002 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2023-02-09 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | 2020-08-12 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | 2020-08-12 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | 2020-08-12 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | 2020-08-12 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | 2020-08-12 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | 2020-08-12 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2020-08-12 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2020-08-12 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2020-08-12 | c0c555d07b60… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2020-08-12 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213967-002 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2023-02-09 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A213967-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2020-08-12 | 1c564ffb4f44… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A213967-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213967-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213967-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213967-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213967-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213967-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213967-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213967-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213967-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213967-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213967-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213967-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213967-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213967-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213967-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213967-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213967-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213967-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213967-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213967-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213967-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213967-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213967-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213967-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213967-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213967-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A213967-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A213967-002 | AA | 1 | 8072bd15b7f6… |
| 2021-03-12 10:30 UTC | 2021-03 | A213967-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A213967-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A213967-001 | AA | 1 | c0c555d07b60… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213967-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213967-002 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A213967-001 | AA | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A213967-002 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A213967-001 | AA | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A213967-002 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213967-001 | AA | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213967-002 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213967-001 | AA | 1 | 9b2671bbb829… |
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 | 213967 ANDA213967 |
| Methocarbamol | METHOCARBAMOL | Redpharm Drug | 44f2aa92-4619-021e-e063-6394a90a296c | 2026-04-21 | Warnings, Adverse reactions | 213967 ANDA213967 |
| Methocarbamol | METHOCARBAMOL | Sportpharm LLC | 64a06ef2-a062-49cc-9526-03c22b6ced2c | 2026-04-03 | Warnings, Adverse reactions | 213967 ANDA213967 |
| Methocarbamol | METHOCARBAMOL | NuCare Pharmaceuticals,Inc. | 36c2c31c-8648-7723-e063-6294a90aec98 | 2026-01-14 | Warnings, Adverse reactions | 213967 ANDA213967 |
| Methocarbamol | METHOCARBAMOL | Asclemed USA, Inc. | 7f297ac6-a580-4539-a770-fe5d15c2b922 | 2025-11-24 | Warnings, Adverse reactions | 213967 ANDA213967 |
| Methocarbamol | METHOCARBAMOL | Bryant Ranch Prepack | f7ab7f11-9b5a-4d3a-a8fc-eee55b1fc006 | 2025-10-13 | Warnings, Adverse reactions | 213967 ANDA213967 |
| Methocarbamol | METHOCARBAMOL | Bryant Ranch Prepack | fdea0332-1ad8-40ef-8cb9-b3c46588155d | 2025-10-13 | Warnings, Adverse reactions | 213967 ANDA213967 |
| Methocarbamol | METHOCARBAMOL | PHOENIX RX LLC | 3b199152-bafc-e14a-e063-6394a90ab283 | 2025-07-29 | Warnings, Adverse reactions | 213967 ANDA213967 |
| Methocarbamol | METHOCARBAMOL | Preferred Pharmaceuticals Inc. | 9169399e-bca1-4c44-9a93-886f3650e44d | 2025-05-19 | Warnings, Adverse reactions | 213967 ANDA213967 |
| Methocarbamol | METHOCARBAMOL | Preferred Pharmaceuticals Inc. | 38d8b457-0c0f-45cb-bf90-965c5a01b198 | 2025-04-23 | Warnings, Adverse reactions | 213967 ANDA213967 |
| Methocarbamol | METHOCARBAMOL | NCS HealthCare of KY, LLC dba Vangard Labs | 32ea8117-4a35-4e2c-93bc-866544b2c3be | 2024-08-12 | Warnings, Adverse reactions | 213967 ANDA213967 |
| Methocarbamol | METHOCARBAMOL | Aurobindo Pharma Limited | f83dd093-ea53-44c1-a40d-682ebc494b62 | 2024-01-18 | Warnings, Adverse reactions | 213967 ANDA213967 59651-341 |