Application 022370
- Type
- NDA
- Sponsor
- CIPHER PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CONZIP | TRAMADOL HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | Yes | Yes |
| 002 | CONZIP | TRAMADOL HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | Yes | No |
| 003 | CONZIP | TRAMADOL HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 300MG | Yes | No |
| 004 | CONZIP | TRAMADOL HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 150MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022370-001 | CONZIP | TRAMADOL HYDROCHLORIDE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2010-05-07 | |
| N022370-002 | CONZIP | TRAMADOL HYDROCHLORIDE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | |
| N022370-003 | CONZIP | TRAMADOL HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | |
| N022370-004 | CONZIP | TRAMADOL HYDROCHLORIDE | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2011-08-01 |
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 | N022370-001 | CONZIP | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2010-05-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022370-002 | CONZIP | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022370-003 | CONZIP | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022370-004 | CONZIP | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2011-08-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022370-001 | CONZIP | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2010-05-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022370-002 | CONZIP | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022370-003 | CONZIP | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022370-004 | CONZIP | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2011-08-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022370-001 | CONZIP | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2010-05-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022370-002 | CONZIP | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022370-003 | CONZIP | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022370-004 | CONZIP | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2011-08-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022370-001 | CONZIP | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2010-05-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022370-002 | CONZIP | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022370-003 | CONZIP | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022370-004 | CONZIP | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2011-08-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022370-001 | CONZIP | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2010-05-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022370-002 | CONZIP | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022370-003 | CONZIP | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022370-004 | CONZIP | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2011-08-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022370-001 | CONZIP | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2010-05-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022370-002 | CONZIP | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022370-003 | CONZIP | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022370-004 | CONZIP | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2011-08-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022370-001 | CONZIP | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2010-05-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022370-002 | CONZIP | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022370-003 | CONZIP | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022370-004 | CONZIP | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2011-08-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022370-001 | CONZIP | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2010-05-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022370-002 | CONZIP | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022370-003 | CONZIP | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022370-004 | CONZIP | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2011-08-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022370-001 | CONZIP | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2010-05-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022370-002 | CONZIP | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022370-003 | CONZIP | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022370-004 | CONZIP | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2011-08-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022370-001 | CONZIP | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2010-05-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022370-002 | CONZIP | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022370-003 | CONZIP | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-05-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022370-004 | CONZIP | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2011-08-01 | d8e5a09893c0… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022370-001 | 7858118 | 2022-04-11 | U-1104 | Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022370-002 | 7858118 | 2022-04-11 | U-1104 | Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022370-003 | 7858118 | 2022-04-11 | U-1104 | Drug product | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022370-001 | 7858118 | 2022-04-11 | U-1104 | Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022370-002 | 7858118 | 2022-04-11 | U-1104 | Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022370-003 | 7858118 | 2022-04-11 | U-1104 | Drug product | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022370-001 | 7858118 | 2022-04-11 | U-1104 | Drug product | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022370-002 | 7858118 | 2022-04-11 | U-1104 | Drug product | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022370-003 | 7858118 | 2022-04-11 | U-1104 | Drug product | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022370-001 | 7858118 | 2022-04-11 | U-1104 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022370-002 | 7858118 | 2022-04-11 | U-1104 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022370-003 | 7858118 | 2022-04-11 | U-1104 | Drug product | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022370-001 | 7858118 | 2022-04-11 | U-1104 | Drug product | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022370-002 | 7858118 | 2022-04-11 | U-1104 | Drug product | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022370-003 | 7858118 | 2022-04-11 | U-1104 | Drug product | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022370-001 | 7858118 | 2022-04-11 | U-1104 | Drug product | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022370-002 | 7858118 | 2022-04-11 | U-1104 | Drug product | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022370-003 | 7858118 | 2022-04-11 | U-1104 | Drug product | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022370-001 | 7858118 | 2022-04-11 | U-1104 | Drug product | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022370-002 | 7858118 | 2022-04-11 | U-1104 | Drug product | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022370-003 | 7858118 | 2022-04-11 | U-1104 | Drug product | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N022370-001 | 7858118 | 2022-04-11 | U-1104 | Drug product | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N022370-002 | 7858118 | 2022-04-11 | U-1104 | Drug product | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N022370-003 | 7858118 | 2022-04-11 | U-1104 | Drug product | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N022370-001 | 7858118 | 2022-04-11 | U-1104 | Drug product | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N022370-002 | 7858118 | 2022-04-11 | U-1104 | Drug product | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N022370-003 | 7858118 | 2022-04-11 | U-1104 | Drug product | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N022370-001 | 7858118 | 2022-04-11 | U-1104 | Drug product | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N022370-002 | 7858118 | 2022-04-11 | U-1104 | Drug product | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N022370-003 | 7858118 | 2022-04-11 | U-1104 | Drug product | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022370-001 | 7858118 | 2022-04-11 | U-1104 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022370-002 | 7858118 | 2022-04-11 | U-1104 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022370-003 | 7858118 | 2022-04-11 | U-1104 | Drug product | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022370-001 | 7858118 | 2022-04-11 | U-1104 | Drug product | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022370-002 | 7858118 | 2022-04-11 | U-1104 | Drug product | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022370-003 | 7858118 | 2022-04-11 | U-1104 | Drug product | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022370-001 | 7858118 | 2022-04-11 | U-1104 | Drug product | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022370-002 | 7858118 | 2022-04-11 | U-1104 | Drug product | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022370-003 | 7858118 | 2022-04-11 | U-1104 | Drug product | ea99ee380514… | |
| 2023-01-26 05:58 UTC | 2023-01 | N022370-001 | 7858118 | 2022-04-11 | U-1104 | Drug product | 3bdfa0b2c4d7… |
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 Extended-Release | TRAMADOL HYDROCHLORIDE | Trigen Laboratories, LLC | c0bc7218-3fd0-4646-96f4-25355fc84aa9 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | 022370 NDA022370 13811-690 13811-691 13811-689 |
| ConZip | TRAMADOL HYDROCHLORIDE | Vertical Pharmaceuticals, LLC | a65b4d05-3a1c-4aa1-848a-d20ac9aaf62f | 2025-12-29 | Boxed warning, Warnings, Adverse reactions | 022370 NDA022370 68025-072 68025-073 68025-071 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 13811-689 | Tramadol Hydrochloride | tramadol hydrochloride | Trigen Laboratories, LLC | NDA AUTHORIZED GENERIC | Current |
| 13811-689 | Tramadol Hydrochloride | tramadol hydrochloride | Trigen Laboratories, LLC | NDA AUTHORIZED GENERIC | Current |
| 13811-689 | Tramadol Hydrochloride | tramadol hydrochloride | Trigen Laboratories, LLC | NDA AUTHORIZED GENERIC | Current |
| 13811-689 | Tramadol Hydrochloride | tramadol hydrochloride | Trigen Laboratories, LLC | NDA AUTHORIZED GENERIC | Current |
| 13811-689 | Tramadol Hydrochloride | tramadol hydrochloride | Trigen Laboratories, LLC | NDA AUTHORIZED GENERIC | Current |
| 13811-689 | Tramadol Hydrochloride | tramadol hydrochloride | Trigen Laboratories, LLC | NDA AUTHORIZED | Current |
| 13811-690 | Tramadol Hydrochloride | tramadol hydrochloride | Trigen Laboratories, LLC | NDA AUTHORIZED GENERIC | Current |
| 13811-690 | Tramadol Hydrochloride | tramadol hydrochloride | Trigen Laboratories, LLC | NDA AUTHORIZED GENERIC | Current |
| 13811-690 | Tramadol Hydrochloride | tramadol hydrochloride | Trigen Laboratories, LLC | NDA AUTHORIZED GENERIC | Current |
| 13811-690 | Tramadol Hydrochloride | tramadol hydrochloride | Trigen Laboratories, LLC | NDA AUTHORIZED GENERIC | Current |
| 13811-690 | Tramadol Hydrochloride | tramadol hydrochloride | Trigen Laboratories, LLC | NDA AUTHORIZED GENERIC | Current |
| 13811-690 | Tramadol Hydrochloride | tramadol hydrochloride | Trigen Laboratories, LLC | NDA AUTHORIZED | Current |
| 13811-691 | Tramadol Hydrochloride | tramadol hydrochloride | Trigen Laboratories, LLC | NDA AUTHORIZED GENERIC | Current |
| 13811-691 | Tramadol Hydrochloride | tramadol hydrochloride | Trigen Laboratories, LLC | NDA AUTHORIZED GENERIC | Current |
| 13811-691 | Tramadol Hydrochloride | tramadol hydrochloride | Trigen Laboratories, LLC | NDA AUTHORIZED GENERIC | Current |
| 13811-691 | Tramadol Hydrochloride | tramadol hydrochloride | Trigen Laboratories, LLC | NDA AUTHORIZED GENERIC | Current |
| 13811-691 | Tramadol Hydrochloride | tramadol hydrochloride | Trigen Laboratories, LLC | NDA AUTHORIZED GENERIC | Current |
| 13811-691 | Tramadol Hydrochloride | tramadol hydrochloride | Trigen Laboratories, LLC | NDA AUTHORIZED | Current |
| 33261-880 | Tramadol Hydrochloride | Tramadol Hydrochloride | Aidarex Pharmaceuticals LLC | NDA | Current |
| 33261-960 | Tramadol Hydrochloride | Tramadol Hydrochloride | Aidarex Pharmaceuticals LLC | NDA | Current |
| 45865-709 | Tramadol Hydrochloride | Tramadol Hydrochloride | Medsource Pharmaceuticals | NDA | Current |
| 45865-709 | Tramadol Hydrochloride | Tramadol Hydrochloride | Medsource Pharmaceuticals | NDA | Current |
| 50436-0821 | Tramadol Hydrochloride | Tramadol Hydrochloride | Unit Dose Services | NDA | Current |
| 53217-960 | Tramadol Hydrochloride | Tramadol Hydrochloride | Aidarex Pharmaceuticals LLC | NDA | Current |
| 55700-293 | Tramadol Hydrochloride | Tramadol Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 55700-293 | Tramadol Hydrochloride | Tramadol Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 61919-002 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | DIRECT RX | NDA | Current |
| 61919-583 | Tramadol Hydrochloride | Tramadol Hydrochloride | Direct Rx | NDA | Current |
| 63187-062 | Tramadol Hydrochloride | Tramadol Hydrochloride | Proficient Rx LP | NDA | Current |
| 63187-615 | Tramadol Hydrochloride | Tramadol Hydrochloride | Proficient Rx LP | NDA | Current |
| 63187-615 | Tramadol Hydrochloride | Tramadol Hydrochloride | Proficient Rx LP | NDA | Current |
| 63187-615 | Tramadol Hydrochloride | Tramadol Hydrochloride | Proficient Rx LP | NDA | Current |
| 63629-4900 | Tramadol Hydrochloride | Tramadol Hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-4900 | Tramadol Hydrochloride | Tramadol Hydrochloride | Bryant Ranch Prepack | NDA | Current |
| 68025-071 | ConZip | tramadol hydrochloride | Vertical Pharmaceuticals, LLC | NDA | Current |
| 68025-071 | ConZip | tramadol hydrochloride | Vertical Pharmaceuticals, LLC | NDA | Current |
| 68025-071 | ConZip | tramadol hydrochloride | Vertical Pharmaceuticals, LLC | NDA | Current |
| 68025-071 | ConZip | tramadol hydrochloride | Vertical Pharmaceuticals, LLC | NDA | Current |
| 68025-071 | ConZip | tramadol hydrochloride | Vertical Pharmaceuticals, LLC | NDA | Current |
| 68025-071 | ConZip | tramadol hydrochloride | Vertical Pharmaceuticals, LLC | NDA | Current |
| 68025-072 | ConZip | tramadol hydrochloride | Vertical Pharmaceuticals, LLC | NDA | Current |
| 68025-072 | ConZip | tramadol hydrochloride | Vertical Pharmaceuticals, LLC | NDA | Current |
| 68025-072 | ConZip | tramadol hydrochloride | Vertical Pharmaceuticals, LLC | NDA | Current |
| 68025-072 | ConZip | tramadol hydrochloride | Vertical Pharmaceuticals, LLC | NDA | Current |
| 68025-072 | ConZip | tramadol hydrochloride | Vertical Pharmaceuticals, LLC | NDA | Current |
| 68025-072 | ConZip | tramadol hydrochloride | Vertical Pharmaceuticals, LLC | NDA | Current |
| 68025-073 | ConZip | tramadol hydrochloride | Vertical Pharmaceuticals, LLC | NDA | Current |
| 68025-073 | ConZip | tramadol hydrochloride | Vertical Pharmaceuticals, LLC | NDA | Current |
| 68025-073 | ConZip | tramadol hydrochloride | Vertical Pharmaceuticals, LLC | NDA | Current |
| 68025-073 | ConZip | tramadol hydrochloride | Vertical Pharmaceuticals, LLC | NDA | Current |
| 68025-073 | ConZip | tramadol hydrochloride | Vertical Pharmaceuticals, LLC | NDA | Current |
| 68025-073 | ConZip | tramadol hydrochloride | Vertical Pharmaceuticals, LLC | NDA | Current |
| 68071-1978 | Tramadol Hydrochloride | Tramadol Hydrochloride | NuCare Pharmaceuticals, Inc. | NDA | Current |
| 68071-1978 | Tramadol Hydrochloride | Tramadol Hydrochloride | NuCare Pharmaceuticals, Inc. | NDA | Current |
| 68788-8920 | Tramadol Hydrochloride | Tramadol Hydrochloride | Preferred Pharmaceuticals Inc. | NDA | Current |
| 68788-8920 | Tramadol Hydrochloride | Tramadol Hydrochloride | Preferred Pharmaceuticals | NDA | Current |
| 69420-5150 | Tramadol Hydrochloride | Tramadol Hydrochloride | SA3, LLC | NDA AUTHORIZED GENERIC | Current |
| 69420-5150 | Tramadol Hydrochloride | Tramadol Hydrochloride | SA3, LLC | NDA AUTHORIZED GENERIC | Current |
| 69467-1001 | Tramadol Hydrochloride | Tramadol Hydrochloride | STA3, LLC | NDA AUTHORIZED GENERIC | Current |
| 69467-1001 | Tramadol Hydrochloride | Tramadol Hydrochloride | STA3, LLC | NDA AUTHORIZED GENERIC | Current |
| 69467-1001 | Tramadol Hydrochloride | Tramadol Hydrochloride | STA3, LLC | NDA AUTHORIZED GENERIC | Current |
| 69677-316 | Tramadol Hydrochloride | Tramadol Hydrochloride | Mas Management Group, Inc. | NDA | Current |
| 76519-1009 | Tramadol Hydrochloride | Tramadol Hydrochloride | H.J. Harkins Company, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84655 | SUPPL | 2026-01-06 |
| 84612 | SUPPL | 2025-12-31 |
| 80076 | SUPPL | 2024-11-04 |
| 77039 | SUPPL | 2023-12-19 |
| 77033 | SUPPL | 2023-12-19 |
| 76940 | SUPPL | 2023-12-18 |
| 76238 | ORIG | 2023-11-03 |
| 68613 | SUPPL | 2021-09-14 |
| 68604 | SUPPL | 2021-09-13 |
| 68603 | SUPPL | 2021-09-13 |
| 66641 | SUPPL | 2021-03-08 |
| 66640 | SUPPL | 2021-03-08 |
| 66560 | SUPPL | 2021-03-05 |
| 60389 | SUPPL | 2019-10-08 |
| 60387 | SUPPL | 2019-10-08 |
| 60369 | SUPPL | 2019-10-08 |
| 55691 | SUPPL | 2018-10-01 |
| 55690 | SUPPL | 2018-10-01 |
| 55598 | SUPPL | 2018-09-24 |
| 55597 | SUPPL | 2018-09-24 |
| 49641 | SUPPL | 2017-08-31 |
| 49603 | SUPPL | 2017-08-30 |
| 46343 | SUPPL | 2016-12-21 |
| 46342 | SUPPL | 2016-12-21 |
| 46338 | SUPPL | 2016-12-21 |
| 46337 | SUPPL | 2016-12-21 |
| 22007 | ORIG | 2011-02-22 |
| 38631 | ORIG | 2010-05-17 |
| 7303 | ORIG | 2010-05-12 |
| 7302 | ORIG | 2009-02-18 |