Application 078026
- Type
- ANDA
- Sponsor
- ROXANE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE | No | No |
| 002 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 20MG BASE | No | No |
| 003 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 30MG BASE | No | No |
| 004 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 40MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078026-001 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-06-29 | ||
| A078026-002 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-06-29 | ||
| A078026-003 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | 2007-06-29 | ||
| A078026-004 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-06-29 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078026-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-06-29 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078026-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-06-29 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078026-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | 2007-06-29 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078026-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-06-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A078026-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-06-29 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A078026-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-06-29 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A078026-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | 2007-06-29 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A078026-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-06-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A078026-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-06-29 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A078026-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-06-29 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A078026-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | 2007-06-29 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A078026-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-06-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078026-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-06-29 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078026-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-06-29 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078026-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | 2007-06-29 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078026-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-06-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078026-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-06-29 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078026-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-06-29 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078026-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | 2007-06-29 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078026-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-06-29 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078026-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-06-29 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078026-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-06-29 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078026-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | 2007-06-29 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078026-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-06-29 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078026-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-06-29 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078026-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-06-29 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078026-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | 2007-06-29 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078026-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-06-29 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A078026-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-06-29 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A078026-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-06-29 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A078026-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | 2007-06-29 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A078026-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-06-29 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A078026-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-06-29 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A078026-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-06-29 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A078026-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | 2007-06-29 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A078026-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-06-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078026-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 2007-06-29 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078026-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | 2007-06-29 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078026-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | 2007-06-29 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078026-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | 2007-06-29 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | Apotex Corp | 087ff0d3-1761-47ea-a8c1-7c4cb679af97 | 2026-09-16 | Boxed warning, Warnings, Adverse reactions | PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE |
| Paroxetine | PAROXETINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc | 605c1d23-c97c-4ea4-92d0-fed351de9d2e | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | PAROXETINE HYDROCHLORIDE |
| Paroxetine | PAROXETINE HYDROCHLORIDE | NorthStar Rx LLC | 118320de-0632-4139-8b13-7428b41da0ac | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | PAROXETINE HYDROCHLORIDE |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 26d37a39-1c53-461c-8834-c67fbffcfe99 | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE |
| PAROXETINE | PAROXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 4d3b4536-7900-223c-e063-6294a90a3d60 | 2026-03-17 | Boxed warning, Warnings, Adverse reactions | PAROXETINE HYDROCHLORIDE |
| PAROXETINE | PAROXETINE HYDROCHLORIDE | Cardinal Health 107, LLC | 333dfd07-61f0-4b86-b4b5-b04adf64e49f | 2025-08-18 | Boxed warning, Warnings, Adverse reactions | PAROXETINE HYDROCHLORIDE |
| Paroxetine | PAROXETINE HYDROCHLORIDE | Aurobindo Pharma Limited | 326e8ab0-6886-4749-9544-885b37070051 | 2025-05-15 | Boxed warning, Warnings, Adverse reactions | PAROXETINE HYDROCHLORIDE |
| Paroxetine | PAROXETINE HYDROCHLORIDE | Zydus Lifesciences Limited | 6d5fcdb2-4d84-4b20-87e3-58a43e567500 | 2024-12-03 | PAROXETINE HYDROCHLORIDE | |
| paroxetine hydrochloride | PAROXETINE HYDROCHLORIDE | Bryant Ranch Prepack | c3c204df-6b7d-42fb-8794-4f38064ed963 | 2024-09-06 | Boxed warning, Warnings, Adverse reactions | paroxetine hydrochloride PAROXETINE HYDROCHLORIDE |
| paroxetine hydrochloride | PAROXETINE HYDROCHLORIDE | Oxford Pharmaceuticals, LLC | 25182b68-8f7a-48e8-9788-6818b0984b29 | 2024-08-09 | Boxed warning, Warnings, Adverse reactions | paroxetine hydrochloride PAROXETINE HYDROCHLORIDE |
| Paroxetine Hydrochloride | PAROXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 5e47c4fb-6070-4cb4-acaa-c6e90199b55c | 2024-01-11 | Boxed warning, Warnings, Adverse reactions | Paroxetine Hydrochloride PAROXETINE HYDROCHLORIDE |
| Paroxetine Hydrochloride | PAROXETINE HYDROCHLORIDE | Lannett Company, Inc. | f22886f5-230c-47e4-9dd8-ffb14c8d6ae4 | 2023-08-22 | Boxed warning, Warnings, Adverse reactions | Paroxetine Hydrochloride PAROXETINE HYDROCHLORIDE |
| PAROXETINE | PAROXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 1801246b-02c3-430f-932a-b18cb0d13d1d | 2018-11-05 | Boxed warning, Warnings, Adverse reactions | PAROXETINE HYDROCHLORIDE |
| PAROXETINE | PAROXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | a7128be7-7023-40c4-aa64-29d52145ae31 | 2018-10-17 | Boxed warning, Warnings, Adverse reactions | PAROXETINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23892 | ORIG | 2007-07-05 |