Application 091607
- Type
- ANDA
- Sponsor
- SUN PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | Yes |
| 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 |
|---|---|---|---|---|---|---|---|
| A091607-001 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | ||
| A091607-002 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | ||
| A091607-003 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 |
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 | A091607-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091607-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091607-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091607-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091607-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091607-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091607-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091607-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091607-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091607-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091607-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091607-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091607-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091607-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091607-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091607-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091607-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091607-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091607-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091607-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091607-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091607-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091607-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091607-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091607-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091607-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091607-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091607-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091607-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091607-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091607-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091607-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091607-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091607-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091607-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091607-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091607-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091607-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091607-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091607-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-12-30 | 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 | A091607-001 | AB2 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091607-002 | AB2 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091607-003 | AB2 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091607-001 | AB2 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091607-002 | AB2 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091607-003 | AB2 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091607-001 | AB2 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091607-002 | AB2 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091607-003 | AB2 | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A091607-001 | AB2 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A091607-002 | AB2 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A091607-003 | AB2 | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A091607-001 | AB2 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091607-002 | AB2 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091607-003 | AB2 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091607-001 | AB2 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091607-002 | AB2 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091607-003 | AB2 | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091607-001 | AB2 | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091607-002 | AB2 | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091607-003 | AB2 | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A091607-001 | AB2 | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A091607-002 | AB2 | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A091607-003 | AB2 | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A091607-001 | AB2 | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A091607-002 | AB2 | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A091607-003 | AB2 | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A091607-001 | AB2 | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A091607-002 | AB2 | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A091607-003 | AB2 | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A091607-001 | AB2 | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A091607-002 | AB2 | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A091607-003 | AB2 | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A091607-001 | AB2 | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A091607-002 | AB2 | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A091607-003 | AB2 | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A091607-001 | AB2 | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A091607-002 | AB2 | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A091607-003 | AB2 | 1 | ea99ee380514… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091607-001 | AB2 | 1 | a67488948f0b… |
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 | Sun Pharmaceutical Industries, Inc. | dc420d50-6192-482d-b3da-3be55870a79a | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | 091607 ANDA091607 47335-533 47335-537 47335-531 |
| Tramadol HCL ER | TRAMADOL HCL | Advanced Rx Pharmacy of Tennessee, LLC | bba287fe-fbf6-65a9-e053-2a95a90a9237 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 091607 ANDA091607 80425-0127 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47335-531 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-531 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-531 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-531 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-531 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-533 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-533 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-533 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-533 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-533 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-537 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-537 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-537 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-537 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-537 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 50436-0824 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Unit Dose Services | ANDA | Current |
| 50436-8788 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Unit Dose Services | ANDA | Current |
| 80425-0127 | Conzip | Tramadol 200mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0127 | Tramadol HCL | Tramadol HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0127 | Tramadol HCL | Tramadol HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0127 | Tramadol HCL | Tramadol HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |