Application 075491
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | TABLET;ORAL | 75MG | No | No |
| 002 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075491-001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2000-04-17 | |
| A075491-002 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2000-04-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075491-001 | AB |
| A075491-002 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075491-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2000-04-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075491-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2000-04-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075491-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2000-04-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075491-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2000-04-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075491-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2000-04-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075491-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2000-04-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075491-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2000-04-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075491-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2000-04-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075491-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2000-04-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075491-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2000-04-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075491-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2000-04-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075491-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2000-04-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075491-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2000-04-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075491-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2000-04-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075491-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2000-04-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075491-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2000-04-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075491-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2000-04-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075491-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2000-04-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075491-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2000-04-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075491-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2000-04-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075491-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2000-04-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075491-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2000-04-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075491-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2000-04-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075491-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2000-04-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075491-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2000-04-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075491-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2000-04-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075491-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2000-04-17 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075491-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2000-04-17 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075491-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | 2000-04-17 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075491-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-04-17 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075491-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | 2000-04-17 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075491-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-04-17 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075491-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | 2000-04-17 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075491-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-04-17 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075491-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2000-04-17 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075491-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2000-04-17 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075491-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | 2000-04-17 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075491-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-04-17 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075491-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | 2000-04-17 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075491-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-04-17 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075491-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075491-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075491-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075491-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075491-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075491-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075491-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075491-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075491-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075491-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075491-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075491-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075491-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075491-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075491-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075491-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075491-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075491-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075491-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075491-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075491-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075491-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075491-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075491-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075491-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075491-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075491-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A075491-002 | AB | 1 | 8072bd15b7f6… |
| 2019-12-13 00:20 UTC | 2019-12 | A075491-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075491-002 | AB | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075491-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075491-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A075491-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A075491-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A075491-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A075491-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A075491-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A075491-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A075491-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A075491-002 | AB | 1 | 3f01610625f2… |
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 | NCS HealthCare of KY, LLC dba Vangard Labs | 4fbe64aa-f8f4-45fa-88ae-e844997703ae | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 075491 ANDA075491 |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | d86e26e0-6e10-4d59-8cc8-94b551774b86 | 2026-03-04 | Boxed warning, Warnings, Adverse reactions | 075491 ANDA075491 |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | Coupler LLC | 47b96919-a8ea-b769-e063-6394a90aa34e | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | 075491 ANDA075491 |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | Aurobindo Pharma Limited | 6563b923-269f-40c3-b992-cbacdfca6e16 | 2025-09-29 | Boxed warning, Warnings, Adverse reactions | 075491 ANDA075491 |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 9a3b97be-afa3-49e6-962f-662b6807e607 | 2025-06-03 | Boxed warning, Warnings, Adverse reactions | 075491 ANDA075491 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-0433 | Bupropion Hydrochloride | bupropion hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0433 | Bupropion Hydrochloride | bupropion hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0435 | Bupropion Hydrochloride | bupropion hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0435 | Bupropion Hydrochloride | bupropion hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0615-7631 | Bupropion Hydrochloride | bupropion hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7632 | Bupropion Hydrochloride | bupropion hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 43063-284 | Bupropion Hydrochloride | bupropion hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-284 | Bupropion Hydrochloride | bupropion hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-284 | Bupropion Hydrochloride | bupropion hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43353-575 | Bupropion Hydrochloride | bupropion hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 51079-943 | Bupropion Hydrochloride | bupropion hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-943 | Bupropion Hydrochloride | bupropion hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-944 | Bupropion Hydrochloride | bupropion hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-944 | Bupropion Hydrochloride | bupropion hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 52959-655 | Bupropion Hydrochloride | bupropion hydrochloride | H.J. Harkins Company, Inc. | ANDA | Current |
| 53808-0214 | Bupropion Hydrochloride | bupropion hydrochloride | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0347 | Bupropion Hydrochloride | bupropion hydrochloride | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0908 | Bupropion Hydrochloride | bupropion hydrochloride | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0910 | Bupropion Hydrochloride | bupropion hydrochloride | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-4394 | Bupropion Hydrochloride | bupropion hydrochloride | Cardinal Health | ANDA | Current |
| 55154-4394 | Bupropion Hydrochloride | bupropion hydrochloride | Cardinal Health | ANDA | Current |
| 55289-733 | Bupropion Hydrochloride | bupropion hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-733 | Bupropion Hydrochloride | bupropion hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-733 | Bupropion Hydrochloride | bupropion hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-733 | Bupropion Hydrochloride | bupropion hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 67046-075 | Bupropion Hydrochloride | bupropion hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-076 | Bupropion Hydrochloride | bupropion hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 67544-406 | Bupropion Hydrochloride | bupropion hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 70518-0788 | Bupropion Hydrochloride | bupropion hydrochloride | REMEDYREPACK INC. | ANDA | Current |