Application 218385
- Type
- ANDA
- Sponsor
- GRANULES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 002 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 150MG | No | No |
| 003 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218385-001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | |
| A218385-002 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | |
| A218385-003 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218385-001 | AB1 |
| A218385-002 | AB1 |
| A218385-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-11-14 07:37:17 | 2026-10 | A218385-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | d4dbc9d85df4… | |
| 2026-11-14 07:37:17 | 2026-10 | A218385-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | d4dbc9d85df4… | |
| 2026-11-14 07:37:17 | 2026-10 | A218385-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | d4dbc9d85df4… | |
| 2026-10-15 13:18:30 | 2026-09 | A218385-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A218385-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A218385-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A218385-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A218385-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A218385-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A218385-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218385-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218385-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218385-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218385-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218385-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218385-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218385-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218385-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218385-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218385-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218385-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218385-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218385-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218385-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218385-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218385-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218385-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218385-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218385-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218385-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218385-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218385-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218385-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | 2680178bc6a6… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A218385-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A218385-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A218385-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | d8e5a09893c0… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218385-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218385-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218385-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2024-10-17 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-11-14 07:37:17 | 2026-10 | A218385-001 | AB1 | 1 | d4dbc9d85df4… |
| 2026-11-14 07:37:17 | 2026-10 | A218385-002 | AB1 | 1 | d4dbc9d85df4… |
| 2026-11-14 07:37:17 | 2026-10 | A218385-003 | AB1 | 1 | d4dbc9d85df4… |
| 2026-10-15 13:18:30 | 2026-09 | A218385-001 | AB1 | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A218385-002 | AB1 | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A218385-003 | AB1 | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A218385-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A218385-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A218385-003 | AB1 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A218385-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218385-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218385-003 | AB1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A218385-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218385-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218385-003 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218385-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218385-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218385-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A218385-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A218385-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A218385-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218385-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218385-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218385-003 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218385-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218385-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218385-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218385-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218385-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218385-003 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218385-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218385-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218385-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A218385-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A218385-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A218385-003 | AB1 | 1 | d8e5a09893c0… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218385-001 | AB1 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218385-002 | AB1 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218385-003 | AB1 | 1 | a50c72e98297… |
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 | BUPROPION HYDROCHLORIDE | Unit Dose Solutions, Inc. | 53c192ca-ac51-cb87-e063-6394a90a6c08 | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | Bupropion hydrochloride BUPROPION HYDROCHLORIDE |
| bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 434aacf8-87f1-44fc-a66b-92ae0022de0e | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| bupropion hydrochloride SR | BUPROPION HYDROCHLORIDE | Major Pharmaceuticals | 67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | cefaaa17-f79a-4ba6-8f97-a59f60e07b75 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | f58ce435-b124-4519-98d8-de2d00f61b01 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 6701af43-bf7d-45c4-a331-a18d16bd68f7 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Amici Pharma, Inc. | fbb587fa-75c0-4f4d-8eaf-f0e7ba8b5c75 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 21be6b3b-add3-43e7-af93-30350aefc89e | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | a72db723-df4b-4bf4-9bdc-05ae82058696 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride XL | BUPROPION HYDROCHLORIDE | Coupler LLC | 512b0ed3-db7d-b273-e063-6394a90a25cc | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Coupler LLC | 507112bd-a082-e85a-e063-6294a90ab2ac | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Cardinal Health 107, LLC | 64934ca2-5655-45a2-9016-ad65b5abf5d3 | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Coupler LLC | 5038440c-1f32-715a-e063-6294a90a889d | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | c71f18b7-36a3-4489-96b4-e8fbec4f73a1 | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Epic Pharma, LLC | f8ad76a2-9f75-4660-973d-34402f314e9c | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 96e78f74-fad0-4ae1-9e68-55e4c6ab2d60 | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | c37bb183-f272-4cae-96e1-7042c1dd7bcf | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 03b1b0a9-0aa2-4039-acce-68ca54abaae4 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | a5417808-f767-48fc-9f5d-c1aeee4e57c3 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | a7553281-be90-47e3-8d2b-b027f6d18d3a | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.