Application 076834
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 150MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076834-001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 |
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 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076834-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2005-07-14 | 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 |
|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | Aurobindo Pharma Limited | 8f86f677-2ebd-43c4-b2dd-2e07d4d54147 | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | Granules Pharmaceuticals Inc. | 61e9cbe3-8211-42f3-b68f-581f56651919 | 2025-11-13 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Actavis Pharma, Inc. | cec41945-8d64-4793-8784-4c2b8ec37b0f | 2025-11-11 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Forfivo XL | BUPROPION HYDROCHLORIDE | Upsher-Smith Laboratories, LLC | 80b01182-dc94-4990-8ebb-55c306d7e536 | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | GlaxoSmithKline LLC | cbc8c074-f080-4489-a5ae-207b5fadeba3 | 2025-11-05 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | e2a988f2-f8d3-4de0-b9f1-49d8c2e4180f | 2025-10-22 | Boxed warning, Warnings, Adverse reactions | bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | e4c450ff-32bd-4359-8449-0b0d0b89a78c | 2025-10-22 | Boxed warning, Warnings, Adverse reactions | bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 722650d8-5ee4-48ba-9827-7c86b1283522 | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 16ffe2ac-4f71-4843-99df-611f53c2f3cd | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| BUPROPION HYDROCHLORIDE SR | BUPROPION HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | f5d774dd-0f51-4a4f-a9d1-8b5f2364b1f7 | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | Accord Healthcare Inc. | 34686e9d-c106-4276-8b47-7460cca8860e | 2025-10-07 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE |
| BUPROPION HYDROCHLORIDE (SR) | BUPROPION HYDROCHLORIDE | Dr. Reddy's Laboratories Inc | 8069c521-c49a-4b6d-baa8-4b0be897d585 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Actavis Pharma, Inc. | a591e33a-52f0-41c8-a00b-4a1afcc3dc4c | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | Aurobindo Pharma Limited | 6563b923-269f-40c3-b992-cbacdfca6e16 | 2025-09-29 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Coupler LLC | 3eec57be-b8ae-cdf8-e063-6394a90a694d | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | b303a0ad-5971-44ab-937c-bcf3ff650358 | 2025-09-15 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 9196568e-aec8-4d56-993e-4cbb78d4a3a6 | 2025-09-05 | Boxed warning, Warnings, Adverse reactions | bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 069e6828-e599-4614-9645-9cf1382ac93e | 2025-09-04 | Boxed warning, Warnings, Adverse reactions | Bupropion hydrochloride BUPROPION HYDROCHLORIDE |
| bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Upsher-Smith Laboratories, LLC | 98d5977f-9b32-46db-bd36-a2c4d1b0710a | 2025-08-29 | Boxed warning, Warnings, Adverse reactions | bupropion hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 3d826804-6427-aae1-e063-6394a90a6593 | 2025-08-29 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44323 | ORIG | 2005-07-28 |