Application 200503
- Type
- ANDA
- Sponsor
- LUPIN LTD
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 |
|---|---|---|---|---|---|---|---|
| A200503-001 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 |
| A200503-002 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | |
| A200503-003 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A200503-001 | AB1 |
| A200503-002 | AB1 |
| A200503-003 | AB1 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-08-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2011-08-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2011-08-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-08-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2011-08-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2011-08-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200503-002 | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200503-003 | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2011-08-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200503-001 | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | RS | 2011-08-29 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A200503-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A200503-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A200503-003 | AB1 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A200503-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A200503-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A200503-003 | AB1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A200503-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200503-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200503-003 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200503-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200503-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200503-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A200503-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200503-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200503-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200503-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200503-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200503-003 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200503-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200503-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200503-003 | AB1 | 1 | b8a1b40f171c… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200503-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200503-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200503-003 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200503-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200503-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200503-003 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A200503-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200503-002 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200503-003 | AB1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200503-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200503-002 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200503-003 | AB1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200503-001 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200503-002 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200503-003 | AB1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200503-001 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200503-002 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200503-003 | AB1 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A200503-001 | AB1 | 1 | 8072bd15b7f6… |
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 | NuCare Pharmaceuticals,Inc. | 93e129c8-64c4-1f6d-e053-2a95a90ac1f8 | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 68071-5078 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Medsource Pharmaceuticals | 1278980b-4068-df57-e063-6394a90a8742 | 2024-02-28 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | 3e0ccb95-3e8e-477c-b4d2-6060ee05f930 | 2023-12-11 | Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Asclemed USA, Inc. | a26ca887-e26c-4c32-8dbd-1fa2eb6db9dc | 2023-02-15 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | 0bff5535-0239-409e-8a2a-99d5ba38cca3 | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 71205-468 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | 3c187736-ea96-4e59-9fe6-cb625a619c63 | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 71205-569 |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | f63facd7-519b-4e2b-b54f-c17fc9ede55f | 2022-03-01 | Boxed warning, Warnings, Adverse reactions | 200503 ANDA200503 71205-463 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45865-969 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | medsource pharmaceuticals | ANDA | Current |
| 45865-976 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | medsource pharmaceuticals | ANDA | Current |
| 50090-5106 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-5107 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50436-0698 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Unit Dose Services | ANDA | Current |
| 61919-818 | TRAMADOL HCL | TRAMADOL HCL | DIRECT RX | ANDA | Current |
| 61919-818 | TRAMADOL HCL | TRAMADOL HCL | DIRECT RX | ANDA | Current |
| 61919-818 | TRAMADOL HCL | TRAMADOL HCL | DIRECT RX | ANDA | Current |
| 61919-818 | TRAMADOL HCL | TRAMADOL HCL | DIRECT RX | ANDA | Current |
| 61919-818 | TRAMADOL HCL | TRAMADOL HCL | DIRECT RX | ANDA | Current |
| 63629-8319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-8319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-8323 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-8323 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 68071-1671 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1671 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2329 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2410 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5078 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5078 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5261 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5261 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68180-697 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-697 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-697 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-697 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-697 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-697 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-697 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-698 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-698 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-698 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-698 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-698 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-698 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-698 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-699 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-699 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-699 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-699 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-699 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-699 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-699 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7601 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7601 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7601 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7601 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7609 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0886 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0886 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0886 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0886 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0886 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0886 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0886 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0942 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0942 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0942 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0942 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0942 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0942 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2795 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2795 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2795 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2795 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 71205-463 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71205-463 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71205-468 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71205-468 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71205-569 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71205-569 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 72189-154 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 80425-0108 | Ultram | Tramadol HCl 100mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0108 | Tramadol HCL | Tramadol HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0108 | Tramadol HCL | Tramadol HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0108 | Tramadol HCL | Tramadol HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0136 | Conzip | Tramadol HCl 200mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0136 | Tramadol HCL | Tramadol HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0136 | Tramadol HCL | Tramadol HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0136 | Tramadol HCL | Tramadol HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76104 | ORIG | 2023-11-02 |