Application 203650
- Type
- ANDA
- Sponsor
- SUN PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | 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 |
|---|---|---|---|---|---|---|---|
| A203650-001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2020-12-31 |
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 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2020-12-31 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2020-12-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2020-12-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2020-12-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2020-12-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2020-12-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | 5aa47cf7b7d7… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2020-12-31 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A203650-001 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2020-12-31 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203650-001 | AB3 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203650-001 | AB3 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203650-001 | AB3 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203650-001 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203650-001 | AB3 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203650-001 | AB3 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203650-001 | AB3 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203650-001 | AB3 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203650-001 | AB3 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A203650-001 | AB3 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203650-001 | AB3 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A203650-001 | AB3 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A203650-001 | AB3 | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A203650-001 | AB3 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A203650-001 | AB3 | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A203650-001 | AB3 | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A203650-001 | AB3 | 1 | 5aa47cf7b7d7… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A203650-001 | AB3 | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A203650-001 | AB3 | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A203650-001 | AB3 | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A203650-001 | AB3 | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A203650-001 | AB3 | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A203650-001 | AB3 | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A203650-001 | AB3 | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A203650-001 | AB3 | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A203650-001 | AB3 | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A203650-001 | AB3 | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A203650-001 | AB3 | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A203650-001 | AB3 | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A203650-001 | AB3 | 1 | cb3db0bc1861… |
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 | Epic Pharma LLC | 9fb44e96-6160-4a4a-90cb-91764c0dcd89 | 2024-06-21 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride XL | BUPROPION HYDROCHLORIDE | Slate Run Pharmaceuticals, LLC | 06d4d890-11ed-4f31-8778-c73432e3ea69 | 2024-06-16 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Slate Run Pharmaceuticals, LLC | 7c4313fa-bb29-dd50-e053-2991aa0a3005 | 2024-06-16 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 87dac2ee-732c-465b-8ffe-e5aeba421425 | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 78ef709a-f835-4b03-92dd-16a4c82af0c1 | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | a18b5460-fcbb-42dd-8b87-197d11a08928 | 2024-05-16 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 77b78d35-40f5-4713-8468-aa09a6c2925d | 2024-05-16 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | e962fb9a-d9fb-49c5-a8b4-0b355b8f829b | 2024-05-09 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Proficient Rx LP | b59d950c-341f-45f1-b5b2-d64ccc799580 | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 339c7157-1c65-40d1-bbcc-c10348d908d3 | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 73167de9-948d-465c-88c0-c7743a79e7f5 | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 6dc4a55b-c0c0-4cbe-988e-da81f0c4f75e | 2024-04-17 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride XL | BUPROPION HYDROCHLORIDE | NuCare Pharmacueticals, Inc. | 15ad0c66-1829-59c3-e063-6394a90a4384 | 2024-04-09 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | c1fa6fce-272b-4497-a958-177f0bafdfc7 | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 62d0dcb5-c70b-4884-9755-740f62a8b31a | 2024-03-14 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 8ae81b03-b447-4a3f-8ed9-ebf75ee52b49 | 2024-03-13 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride XL | BUPROPION HYDROCHLORIDE | Proficient Rx LP | dfd5f264-d4fd-4441-88b1-48086c7c0616 | 2024-03-01 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 8d80f882-1887-4d73-b09f-e98fd7ef2acb | 2024-02-06 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Alembic Pharmaceuticals Limited | ef0bb8f2-7710-4236-8b47-57b74c8bca3e | 2024-01-10 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | dfb45438-1116-48f2-9bfe-776ebbf1e119 | 2023-12-09 | Boxed warning, Warnings, Adverse reactions | BUPROPION 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 |
|---|---|---|---|---|---|
| 63304-724 | Bupropion hydrochloride | Bupropion hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-724 | Bupropion hydrochloride | Bupropion hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-724 | Bupropion hydrochloride | Bupropion hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |