Application 090404
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090404-001 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090404-001 | AB |
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 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A090404-001 | TRAMADOL HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2011-01-31 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090404-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090404-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090404-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090404-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090404-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090404-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090404-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090404-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090404-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090404-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090404-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090404-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090404-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090404-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090404-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090404-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090404-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090404-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090404-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090404-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090404-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090404-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090404-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090404-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090404-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090404-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A090404-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090404-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090404-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090404-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A090404-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A090404-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090404-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090404-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090404-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090404-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A090404-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A090404-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090404-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A090404-001 | AB | 1 | f41ea6bd6efb… |
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 | 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 |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | TruPharma, LLC | aea56ff9-94ac-47a8-8f15-8790d538973b | 2023-01-25 | Boxed warning, Warnings, Adverse reactions | Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE |
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 |
|---|---|---|---|---|---|
| 0904-6365 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Major Pharmaceuticals | ANDA | Current |
| 0904-6365 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Major Pharmaceuticals | ANDA | Current |
| 51655-182 | Tramadol HCl | Tramadol HCl | Northwind Pharmaceuticals | ANDA | Current |
| 52959-688 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | H.J. Harkins Company Inc. | ANDA | Current |
| 58118-0319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-0319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 60760-319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-597 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | DirectRX | ANDA | Current |
| 61919-597 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | DirectRX | ANDA | Current |
| 65841-754 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Cadila Healthcare Limited | ANDA | Current |
| 65841-754 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Cadila Healthcare Limited | ANDA | Current |
| 65841-754 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Cadila Healthcare Limited | ANDA | Current |
| 65841-754 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Zydus Lifesciences Limited | ANDA | Current |
| 65841-754 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Cadila Healthcare Limited | ANDA | Current |
| 67046-731 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-1649 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1649 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | RedPharm Drug, Inc. | ANDA | Current |
| 68071-3280 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3321 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4070 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,In | ANDA | Current |
| 68071-4070 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4070 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4165 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4165 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4165 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68382-319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68788-6929 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 71205-066 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71205-066 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71335-1003 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-1003 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76214 | ORIG | 2023-11-03 |