Application 201331
- Type
- ANDA
- Sponsor
- WOCKHARDT LTD
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 |
|---|---|---|---|---|---|---|---|
| A201331-001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | ||
| A201331-002 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | ||
| A201331-003 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 |
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 | A201331-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201331-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201331-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201331-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201331-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201331-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A201331-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A201331-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A201331-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201331-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201331-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201331-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201331-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201331-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201331-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201331-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201331-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201331-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201331-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201331-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201331-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201331-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201331-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201331-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201331-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201331-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201331-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A201331-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A201331-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A201331-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201331-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201331-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201331-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201331-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201331-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201331-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201331-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201331-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201331-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A201331-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2012-08-30 | 8072bd15b7f6… |
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. | 02275c51-6b3e-434a-bdb5-99135e73f1a4 | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | bf5e933c-8a84-4dd7-a05d-6c4a82b6c965 | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | Bupropion hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 350336bf-57b1-4d2f-bf25-956bb6023c07 | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | Bupropion hydrochloride BUPROPION HYDROCHLORIDE |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 82bcdd72-9146-4c8d-a8aa-f92015864605 | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | af5b1cc8-f078-4a7b-b64a-4cb2de1e5721 | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | Bupropion hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride XL | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | eb25adb1-9841-42ce-aa22-718fb0fba5dd | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 8499470a-8d01-4348-b67b-8f49728031cb | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 5c111cf0-0199-4a4d-8138-81579af4c14d | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | Bupropion hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 4c9a5dc3-bebe-431a-b550-ce46c6c6b01e | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | Bupropion hydrochloride BUPROPION HYDROCHLORIDE |
| 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 | BUPROPION HYDROCHLORIDE | REMEDYREPACK INC. | 136f29fa-a859-4efb-8365-1382716d6f8f | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | bupropion hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Proficient Rx LP | f1703bfd-be36-4fde-8e67-df0fb5d93369 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | Bupropion hydrochloride 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 | BUPROPION HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | b5c12c9a-62eb-481a-8099-7ad35242f7bf | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride 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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 33261-449 | Bupropion Hydrochloride SR | Bupropion Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55648-101 | Bupropion Hydrochloride | Bupropion Hydrochloride | Wockhardt Limited | ANDA | Current |
| 55648-105 | Bupropion Hydrochloride | Bupropion Hydrochloride | Wockhardt Limited | ANDA | Current |
| 55648-107 | Bupropion Hydrochloride | Bupropion Hydrochloride | Wockhardt Limited | ANDA | Current |
| 64679-101 | Bupropion Hydrochloride | Bupropion Hydrochloride | Wockhardt USA LLC. | ANDA | Current |
| 64679-101 | Bupropion Hydrochloride | Bupropion Hydrochloride | Wockhardt USA LLC. | ANDA | Current |
| 64679-105 | Bupropion Hydrochloride | Bupropion Hydrochloride | Wockhardt USA LLC. | ANDA | Current |
| 64679-105 | Bupropion Hydrochloride | Bupropion Hydrochloride | Wockhardt USA LLC. | ANDA | Current |
| 64679-107 | Bupropion Hydrochloride | Bupropion Hydrochloride | Wockhardt USA LLC. | ANDA | Current |
| 64679-107 | Bupropion Hydrochloride | Bupropion Hydrochloride | Wockhardt USA LLC. | ANDA | Current |