Application 205257
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 002 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 200MG | No | No |
| 003 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 300MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205257-001 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | ||
| A205257-002 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | ||
| A205257-003 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 |
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 | A205257-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205257-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205257-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205257-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205257-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205257-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205257-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205257-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205257-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205257-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205257-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205257-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205257-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205257-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205257-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205257-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205257-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205257-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205257-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205257-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205257-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205257-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205257-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205257-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205257-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205257-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205257-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A205257-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A205257-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A205257-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205257-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205257-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205257-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205257-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205257-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205257-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205257-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205257-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205257-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A205257-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-12-22 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205257-001 | AB1 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205257-002 | AB1 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205257-003 | AB1 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A205257-001 | AB1 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A205257-002 | AB1 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A205257-003 | AB1 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A205257-001 | AB1 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A205257-002 | AB1 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A205257-003 | AB1 | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A205257-001 | AB1 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A205257-002 | AB1 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A205257-003 | AB1 | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A205257-001 | AB1 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A205257-002 | AB1 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A205257-003 | AB1 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A205257-001 | AB1 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A205257-002 | AB1 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A205257-003 | AB1 | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205257-001 | AB1 | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205257-002 | AB1 | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205257-003 | AB1 | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A205257-001 | AB1 | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A205257-002 | AB1 | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A205257-003 | AB1 | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A205257-001 | AB1 | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A205257-002 | AB1 | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A205257-003 | AB1 | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A205257-001 | AB1 | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A205257-002 | AB1 | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A205257-003 | AB1 | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A205257-001 | AB1 | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A205257-002 | AB1 | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A205257-003 | AB1 | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A205257-001 | AB1 | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A205257-002 | AB1 | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A205257-003 | AB1 | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A205257-001 | AB1 | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A205257-002 | AB1 | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A205257-003 | AB1 | 1 | ea99ee380514… |
| 2022-09-29 23:25 UTC | 2022-09 | A205257-001 | AB1 | 1 | e64feba35796… |
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 |
|---|---|---|---|---|---|---|
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | d7e75fd3-18d1-4370-bb63-c9dd8a2c1719 | 2025-01-01 | Boxed warning, Warnings, Adverse reactions | Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Cranbury Pharmaceuticals, LLC | 1d4af58f-17f3-4cbd-870c-098ace954872 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f4ea18b0-2cbd-0d42-e053-2995a90a9264 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Quality Care Products, LLC | f79fda81-f09a-4a08-babc-6bd3bb3ee661 | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Quality Care Products, LLC | 68484531-f908-473f-a422-f37234de9691 | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Quality Care Products, LLC | 7e421fb6-737c-49b3-b299-50511e281a4d | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 27460cc6-0782-7838-e063-6394a90a19f1 | 2024-11-18 | Boxed warning, Warnings, Adverse reactions | Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE |
| tramadol hydrochloride | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 6ebc5864-c222-4400-a9b2-f66fd6fb0da6 | 2024-11-04 | Boxed warning, Warnings, Adverse reactions | tramadol hydrochloride TRAMADOL HYDROCHLORIDE |
| TRAMADOL HCL ER | TRAMADOL HCL | DIRECT RX | 5285f056-c32c-4e7a-bec6-3a726aa23d5a | 2024-10-17 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE |
| tramadol hydrochloride | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 1cd3caee-bf54-7aba-e063-6394a90ad8cb | 2024-10-04 | Boxed warning, Warnings, Adverse reactions | tramadol hydrochloride TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f44c53ec-26ea-d272-e053-2a95a90a5e59 | 2024-09-09 | Boxed warning, Warnings, Adverse reactions | Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 8cc09b31-6067-44ec-8aba-ea7bb1a1f448 | 2024-08-28 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | b2f3f007-6dda-4532-9f7f-d93f6e65254c | 2024-08-28 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 93c9c960-afbf-6d3d-e053-2995a90a8d15 | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE |
| tramadol hydrochloride | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | 2236031d-8596-4c21-8b16-83aa3e4122c1 | 2024-07-01 | Boxed warning, Warnings, Adverse reactions | tramadol hydrochloride TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 93e129c8-64c4-1f6d-e053-2a95a90ac1f8 | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | e90d4ef3-8b90-41b7-bf96-340852e89b5f | 2024-04-01 | Boxed warning, Warnings, Adverse reactions | Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Medsource Pharmaceuticals | 1278980b-4068-df57-e063-6394a90a8742 | 2024-02-28 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | 3e0ccb95-3e8e-477c-b4d2-6060ee05f930 | 2023-12-11 | Warnings, Adverse reactions | Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Asclemed USA, Inc. | a26ca887-e26c-4c32-8dbd-1fa2eb6db9dc | 2023-02-15 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-4152 | Tramadol Hydrochloride | tramadol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4152 | Tramadol Hydrochloride | tramadol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4152 | Tramadol Hydrochloride | tramadol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4152 | Tramadol Hydrochloride | tramadol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4152 | Tramadol Hydrochloride | tramadol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4153 | Tramadol Hydrochloride | tramadol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4153 | Tramadol Hydrochloride | tramadol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4153 | Tramadol Hydrochloride | tramadol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4153 | Tramadol Hydrochloride | tramadol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4153 | Tramadol Hydrochloride | tramadol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4154 | Tramadol Hydrochloride | tramadol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4154 | Tramadol Hydrochloride | tramadol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4154 | Tramadol Hydrochloride | tramadol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4154 | Tramadol Hydrochloride | tramadol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4154 | Tramadol Hydrochloride | tramadol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 68788-7284 | Tramadol Hydrochloride | tramadol hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76124 | ORIG | 2023-11-03 |