Application 210081
- Type
- ANDA
- Sponsor
- TWI PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 150MG | No | No |
| 002 | BUPROPION HYDROCHLORIDE | BUPROPION 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 |
|---|---|---|---|---|---|---|---|
| A210081-001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2017-11-03 | ||
| A210081-002 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2017-11-03 |
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 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2017-11-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2017-11-03 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2017-11-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2017-11-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2017-11-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2017-11-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | A210081-001 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210081-002 | AB3 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210081-001 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210081-002 | AB3 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210081-001 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210081-002 | AB3 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210081-001 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210081-002 | AB3 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210081-001 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210081-002 | AB3 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210081-001 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210081-002 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210081-001 | AB3 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210081-002 | AB3 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210081-001 | AB3 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210081-002 | AB3 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210081-001 | AB3 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210081-002 | AB3 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210081-001 | AB3 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210081-002 | AB3 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210081-001 | AB3 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210081-002 | AB3 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210081-001 | AB3 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A210081-002 | AB3 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210081-001 | AB3 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210081-002 | AB3 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A210081-001 | AB3 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A210081-002 | AB3 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A210081-001 | AB3 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A210081-002 | AB3 | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A210081-001 | AB3 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A210081-002 | AB3 | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A210081-001 | AB3 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A210081-002 | AB3 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A210081-001 | AB3 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A210081-002 | AB3 | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210081-001 | AB3 | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210081-002 | AB3 | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A210081-001 | AB3 | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A210081-002 | AB3 | 1 | 5aa47cf7b7d7… |
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 |
|---|---|---|---|---|---|---|
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 9d5360f5-f747-4baf-8e6c-ddca1a9c871a | 2024-11-01 | Boxed warning, Warnings, Adverse reactions | 210081 ANDA210081 |
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 64be3113-837a-48f3-9f9e-400529c9ee94 | 2024-09-05 | Boxed warning, Warnings, Adverse reactions | 210081 ANDA210081 71335-1114 |
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 62d0dcb5-c70b-4884-9755-740f62a8b31a | 2024-03-14 | Boxed warning, Warnings, Adverse reactions | 210081 ANDA210081 |
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 8ae81b03-b447-4a3f-8ed9-ebf75ee52b49 | 2024-03-13 | Boxed warning, Warnings, Adverse reactions | 210081 ANDA210081 |
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | ef8ef9ba-ab2a-4af9-ac11-12dd1b603a4a | 2023-06-29 | Boxed warning, Warnings, Adverse reactions | 210081 ANDA210081 50090-5334 |
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | Proficient Rx LP | 2af578d8-a7f8-4da3-b126-390a0e950fad | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 210081 ANDA210081 71205-967 71205-968 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24979-101 | Bupropion Hydrochloride | bupropion hydrochloride | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-101 | Bupropion Hydrochloride | bupropion hydrochloride | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-102 | Bupropion Hydrochloride | bupropion hydrochloride | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-102 | Bupropion Hydrochloride | bupropion hydrochloride | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 50090-5334 | Bupropion Hydrochloride | bupropion hydrochloride | A-S Medication Solutions | ANDA | Current |
| 51407-206 | Bupropion Hydrochloride | bupropion hydrochloride | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-206 | Bupropion Hydrochloride | bupropion hydrochloride | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-206 | Bupropion Hydrochloride | bupropion hydrochloride | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-206 | Bupropion Hydrochloride | bupropion hydrochloride | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-206 | Bupropion Hydrochloride | bupropion hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-207 | Bupropion Hydrochloride | bupropion hydrochloride | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-207 | Bupropion Hydrochloride | bupropion hydrochloride | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-207 | Bupropion Hydrochloride | bupropion hydrochloride | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-207 | Bupropion Hydrochloride | bupropion hydrochloride | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-207 | Bupropion Hydrochloride | bupropion hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 68788-7863 | Bupropion Hydrochloride | bupropion hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 71205-967 | Bupropion Hydrochloride | bupropion hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-967 | Bupropion Hydrochloride | bupropion hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-968 | Bupropion Hydrochloride | bupropion hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-968 | Bupropion Hydrochloride | bupropion hydrochloride | Proficient Rx LP | ANDA | Current |
| 71335-1114 | Bupropion Hydrochloride | bupropion hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1114 | Bupropion Hydrochloride | bupropion hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71610-346 | Bupropion Hydrochloride | bupropion hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 72789-112 | Bupropion Hydrochloride | bupropion hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-112 | Bupropion Hydrochloride | bupropion hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-112 | Bupropion Hydrochloride | bupropion hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-112 | Bupropion Hydrochloride | bupropion hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-120 | Bupropion Hydrochloride | bupropion hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-120 | Bupropion Hydrochloride | bupropion hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-120 | Bupropion Hydrochloride | bupropion hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-120 | Bupropion Hydrochloride | bupropion hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |