Application 208181
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | TABLET;ORAL | 2MG | No | No |
| 002 | TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | TABLET;ORAL | 4MG | No | No |
| 003 | TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | TABLET;ORAL | 12MG | No | No |
| 004 | TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | TABLET;ORAL | 16MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208181-001 | TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2017-12-08 | ||
| A208181-002 | TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2017-12-08 | ||
| A208181-003 | TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | 12MG | TABLET / ORAL | 2017-12-08 | ||
| A208181-004 | TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | 16MG | TABLET / ORAL | 2017-12-08 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208181-001 | TIAGABINE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2017-12-08 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208181-002 | TIAGABINE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2017-12-08 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208181-003 | TIAGABINE HYDROCHLORIDE | 12MG | TABLET / ORAL | 2017-12-08 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208181-004 | TIAGABINE HYDROCHLORIDE | 16MG | TABLET / ORAL | 2017-12-08 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A208181-001 | TIAGABINE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2017-12-08 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A208181-002 | TIAGABINE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2017-12-08 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A208181-003 | TIAGABINE HYDROCHLORIDE | 12MG | TABLET / ORAL | 2017-12-08 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A208181-004 | TIAGABINE HYDROCHLORIDE | 16MG | TABLET / ORAL | 2017-12-08 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A208181-001 | TIAGABINE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2017-12-08 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A208181-002 | TIAGABINE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2017-12-08 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A208181-003 | TIAGABINE HYDROCHLORIDE | 12MG | TABLET / ORAL | 2017-12-08 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A208181-004 | TIAGABINE HYDROCHLORIDE | 16MG | TABLET / ORAL | 2017-12-08 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208181-001 | TIAGABINE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2017-12-08 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208181-002 | TIAGABINE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2017-12-08 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208181-003 | TIAGABINE HYDROCHLORIDE | 12MG | TABLET / ORAL | 2017-12-08 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208181-004 | TIAGABINE HYDROCHLORIDE | 16MG | TABLET / ORAL | 2017-12-08 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208181-001 | TIAGABINE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2017-12-08 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208181-002 | TIAGABINE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2017-12-08 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208181-003 | TIAGABINE HYDROCHLORIDE | 12MG | TABLET / ORAL | 2017-12-08 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208181-004 | TIAGABINE HYDROCHLORIDE | 16MG | TABLET / ORAL | 2017-12-08 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208181-001 | TIAGABINE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2017-12-08 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208181-002 | TIAGABINE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2017-12-08 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208181-003 | TIAGABINE HYDROCHLORIDE | 12MG | TABLET / ORAL | 2017-12-08 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208181-004 | TIAGABINE HYDROCHLORIDE | 16MG | TABLET / ORAL | 2017-12-08 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208181-001 | TIAGABINE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2017-12-08 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208181-002 | TIAGABINE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2017-12-08 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208181-003 | TIAGABINE HYDROCHLORIDE | 12MG | TABLET / ORAL | 2017-12-08 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208181-004 | TIAGABINE HYDROCHLORIDE | 16MG | TABLET / ORAL | 2017-12-08 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A208181-001 | TIAGABINE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2017-12-08 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A208181-002 | TIAGABINE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2017-12-08 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A208181-003 | TIAGABINE HYDROCHLORIDE | 12MG | TABLET / ORAL | 2017-12-08 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A208181-004 | TIAGABINE HYDROCHLORIDE | 16MG | TABLET / ORAL | 2017-12-08 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A208181-001 | TIAGABINE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2017-12-08 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A208181-002 | TIAGABINE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2017-12-08 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A208181-003 | TIAGABINE HYDROCHLORIDE | 12MG | TABLET / ORAL | 2017-12-08 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A208181-004 | TIAGABINE HYDROCHLORIDE | 16MG | TABLET / ORAL | 2017-12-08 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208181-001 | TIAGABINE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2017-12-08 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208181-002 | TIAGABINE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2017-12-08 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208181-003 | TIAGABINE HYDROCHLORIDE | 12MG | TABLET / ORAL | 2017-12-08 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208181-004 | TIAGABINE HYDROCHLORIDE | 16MG | TABLET / ORAL | 2017-12-08 | 3a93d1ddd44b… |
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 | A208181-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208181-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208181-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208181-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A208181-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A208181-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A208181-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A208181-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A208181-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A208181-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A208181-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A208181-004 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A208181-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A208181-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A208181-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A208181-004 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A208181-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A208181-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A208181-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A208181-004 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A208181-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A208181-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A208181-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A208181-004 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208181-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208181-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208181-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208181-004 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A208181-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A208181-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A208181-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A208181-004 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A208181-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A208181-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A208181-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A208181-004 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A208181-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A208181-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A208181-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A208181-004 | AB | 1 | c0c555d07b60… |
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 |
|---|---|---|---|---|---|---|
| Tiagabine Hydrochloride | TIAGABINE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 953ef3cc-e3cb-480f-b9ea-256520fd62b8 | 2021-09-30 | Warnings, Adverse reactions | Tiagabine Hydrochloride TIAGABINE HYDROCHLORIDE |
| Tiagabine Hydrochloride | TIAGABINE HYDROCHLORIDE | Novadoz Pharmaceuticals LLC | 7c034fe0-cdac-49e1-8e39-592846ea3bec | 2021-03-01 | Warnings, Adverse reactions | Tiagabine Hydrochloride TIAGABINE HYDROCHLORIDE |
| TIAGABINE HYDROCHLORIDE | TIAGABINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 7eeb2d81-c5d7-46a0-aa5c-149b55df71bd | 2018-11-02 | Warnings, Adverse reactions | TIAGABINE HYDROCHLORIDE TIAGABINE 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 |
|---|---|---|---|---|---|
| 69238-1104 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1104 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1104 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1104 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1104 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1104 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1105 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1105 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1105 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1105 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1105 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1105 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1106 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1106 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1106 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1106 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1106 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1106 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1107 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1107 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1107 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1107 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1107 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1107 | Tiagabine Hydrochloride | Tiagabine | Amneal Pharmaceuticals NY LLC | ANDA | Current |