Application 090942
- Type
- ANDA
- Sponsor
- MYLAN
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 |
|---|---|---|---|---|---|---|---|
| A090942-001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | ||
| A090942-002 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A090942-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090942-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090942-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090942-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090942-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090942-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090942-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090942-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090942-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090942-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090942-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090942-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090942-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090942-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090942-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090942-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090942-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090942-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090942-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090942-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090942-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090942-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090942-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090942-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090942-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090942-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090942-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090942-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090942-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090942-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090942-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090942-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090942-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090942-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090942-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090942-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A090942-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A090942-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090942-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090942-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2010-07-14 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-09-15 20:21 UTC | 2019-09 | A090942-002 | AB3 | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090942-001 | AB3 | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A090942-002 | AB3 | 1 | ea99ee380514… |
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 | REMEDYREPACK INC. | 4cc3327b-92c5-4667-ae16-3e95eafcf4d8 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 30c370c2-f2b7-4335-ba55-e8c8f4059092 | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | REMEDYREPACK INC. | 080853c0-fcab-4645-9ddc-4946e895ac5f | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride XL | BUPROPION HYDROCHLORIDE | Major Pharmaceuticals | aa3d3e5b-74a3-47f6-b9aa-d6e248e950e5 | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | REMEDYREPACK INC. | c60855ca-4fa0-4004-ad19-4abb61100c43 | 2026-07-22 | Boxed warning, Warnings, Adverse reactions | Bupropion hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride XL | BUPROPION HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | eb946d81-b4f4-42e9-aa7a-31d76d15629c | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | REMEDYREPACK INC. | 740534d3-59b5-4938-8e38-16275a14438c | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride XL | BUPROPION HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | 1af14d2e-c64d-44b7-a402-8869e8e30661 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride XL | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 9aa3753f-1a0e-4faa-995f-67e29b320737 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride XL | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | b2e6c30f-a33c-4854-ab19-bc9f65880374 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | a613cfd3-1aa1-49c5-b742-b105c97d73f1 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | bupropion hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Actavis Pharma, Inc. | df923448-4f81-47af-8e55-f7359746b05f | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Coupler LLC | 5604eb14-bab4-4f06-e063-6294a90a6920 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | Bupropion hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 867d3876-6974-4e89-bc45-9e60e84b401c | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| 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 | BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 362504fd-2f0a-c097-e063-6394a90ac0fc | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | American Health Packaging | 88c980c8-aaa8-4378-9ac2-24d588640caa | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| BuPROPion Hydrochloride | BUPROPION HYDROCHLORIDE | American Health Packaging | 1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8 | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | BuPROPion Hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | REMEDYREPACK INC. | c76f2f9f-3999-4bdd-8ec3-e0066318d378 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Northwind Health Company, LLC | 0865f8cf-1d7f-0e67-e063-6294a90a2f4d | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-2008 | Bupropion Hydrochloride | bupropion hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2008 | Bupropion Hydrochloride | bupropion hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2008 | Bupropion Hydrochloride | bupropion hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2009 | Bupropion Hydrochloride | bupropion hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2009 | Bupropion Hydrochloride | bupropion hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2009 | Bupropion Hydrochloride | bupropion hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 51079-047 | Bupropion Hydrochloride | bupropion hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-109 | Bupropion Hydrochloride | bupropion hydrochloride | Mylan Institutional Inc. | ANDA | Current |