Application 020031
- Type
- NDA
- Sponsor
- APOTEX TECHNOLOGIES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PAXIL | PAROXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE | Yes | No |
| 002 | PAXIL | PAROXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 20MG BASE | Yes | No |
| 003 | PAXIL | PAROXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 30MG BASE | Yes | No |
| 004 | PAXIL | PAROXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 50MG BASE | No | No |
| 005 | PAXIL | PAROXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 40MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020031-001 | PAXIL | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 |
| N020031-002 | PAXIL | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 |
| N020031-003 | PAXIL | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 |
| N020031-004 | PAXIL | PAROXETINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 1992-12-29 | ||
| N020031-005 | PAXIL | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-12-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020031-001 | AB |
| N020031-002 | AB |
| N020031-003 | AB |
| N020031-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020031-001 | PAXIL | EQ 10MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020031-002 | PAXIL | EQ 20MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020031-003 | PAXIL | EQ 30MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020031-004 | PAXIL | EQ 50MG BASE | TABLET / ORAL | 1992-12-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020031-005 | PAXIL | EQ 40MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-12-29 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N020031-001 | PAXIL | EQ 10MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020031-002 | PAXIL | EQ 20MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020031-003 | PAXIL | EQ 30MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020031-004 | PAXIL | EQ 50MG BASE | TABLET / ORAL | 1992-12-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020031-005 | PAXIL | EQ 40MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-12-29 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020031-001 | PAXIL | EQ 10MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020031-002 | PAXIL | EQ 20MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020031-003 | PAXIL | EQ 30MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020031-004 | PAXIL | EQ 50MG BASE | TABLET / ORAL | 1992-12-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020031-005 | PAXIL | EQ 40MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-12-29 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020031-001 | PAXIL | EQ 10MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020031-002 | PAXIL | EQ 20MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020031-003 | PAXIL | EQ 30MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020031-004 | PAXIL | EQ 50MG BASE | TABLET / ORAL | 1992-12-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020031-005 | PAXIL | EQ 40MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-12-29 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020031-001 | PAXIL | EQ 10MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020031-002 | PAXIL | EQ 20MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020031-003 | PAXIL | EQ 30MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020031-004 | PAXIL | EQ 50MG BASE | TABLET / ORAL | 1992-12-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020031-005 | PAXIL | EQ 40MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-12-29 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020031-001 | PAXIL | EQ 10MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020031-002 | PAXIL | EQ 20MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020031-003 | PAXIL | EQ 30MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020031-004 | PAXIL | EQ 50MG BASE | TABLET / ORAL | 1992-12-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020031-005 | PAXIL | EQ 40MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-12-29 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020031-001 | PAXIL | EQ 10MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020031-002 | PAXIL | EQ 20MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020031-003 | PAXIL | EQ 30MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020031-004 | PAXIL | EQ 50MG BASE | TABLET / ORAL | 1992-12-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020031-005 | PAXIL | EQ 40MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-12-29 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020031-001 | PAXIL | EQ 10MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020031-002 | PAXIL | EQ 20MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020031-003 | PAXIL | EQ 30MG BASE | TABLET / ORAL | AB | RLD | 1992-12-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020031-004 | PAXIL | EQ 50MG BASE | TABLET / ORAL | 1992-12-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020031-005 | PAXIL | EQ 40MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-12-29 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020031-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020031-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020031-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020031-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N020031-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020031-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020031-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020031-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020031-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020031-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020031-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020031-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020031-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020031-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020031-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020031-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020031-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020031-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020031-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020031-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020031-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020031-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020031-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020031-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020031-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020031-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020031-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020031-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020031-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020031-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020031-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020031-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020031-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020031-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020031-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020031-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020031-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020031-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020031-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020031-005 | AB | 1 | 5bbf6a4d5a75… |
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 | 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 | PAROXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | e63fe922-b35a-406c-8737-f3f5e6d5a30d | 2026-05-27 | 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 | 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 | REMEDYREPACK INC. | 98d4f767-06e3-4d9b-b1ad-4b31f7e36130 | 2026-02-17 | 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 | Oxford Pharmaceuticals, LLC | 25182b68-8f7a-48e8-9788-6818b0984b29 | 2024-08-09 | Boxed warning, Warnings, Adverse reactions | 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 | Lannett Company, Inc. | f22886f5-230c-47e4-9dd8-ffb14c8d6ae4 | 2023-08-22 | Boxed warning, Warnings, Adverse reactions | 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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60505-3663 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-3663 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-3663 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-3664 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-3664 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-3664 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-3665 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-3665 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-3665 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-3666 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-3666 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-3666 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-3666 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-4517 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-4517 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-4517 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-4517 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-4517 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-4518 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-4518 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-4518 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-4518 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-4518 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-4519 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-4519 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-4519 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-4519 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-4519 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-4520 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-4520 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-4520 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-4520 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-4520 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 70518-2500 | PAXIL | paroxetine hydrochloride | REMEDYREPACK INC. | NDA | Current |
| 70518-2636 | PAXIL | paroxetine hydrochloride | REMEDYREPACK INC. | NDA | Current |
| 70518-2636 | PAXIL | paroxetine hydrochloride | REMEDYREPACK INC. | NDA | Current |
| 70518-2636 | PAXIL | paroxetine hydrochloride | REMEDYREPACK INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80479 | SUPPL | 2024-12-03 |
| 80457 | SUPPL | 2024-12-02 |
| 80456 | SUPPL | 2024-12-02 |
| 76590 | SUPPL | 2023-11-16 |
| 68842 | SUPPL | 2021-10-01 |
| 68841 | SUPPL | 2021-10-01 |
| 69745 | SUPPL | 2021-09-30 |
| 68726 | SUPPL | 2021-09-23 |
| 66182 | SUPPL | 2021-02-11 |
| 66181 | SUPPL | 2021-02-11 |
| 66134 | SUPPL | 2021-02-09 |
| 46812 | SUPPL | 2017-01-13 |
| 46811 | SUPPL | 2017-01-13 |
| 46694 | SUPPL | 2017-01-06 |
| 12148 | SUPPL | 2014-07-29 |
| 1926 | SUPPL | 2014-07-23 |
| 41125 | SUPPL | 2014-01-16 |
| 34190 | SUPPL | 2012-12-31 |
| 1925 | SUPPL | 2012-12-21 |
| 34191 | SUPPL | 2012-04-17 |
| 21056 | SUPPL | 2012-04-12 |
| 34189 | SUPPL | 2011-07-12 |
| 34186 | SUPPL | 2011-07-12 |
| 1924 | SUPPL | 2011-07-12 |
| 1919 | SUPPL | 2011-07-12 |
| 34192 | SUPPL | 2011-03-28 |
| 12147 | SUPPL | 2011-03-28 |
| 12146 | SUPPL | 2011-03-28 |
| 21057 | SUPPL | 2011-03-24 |
| 1923 | SUPPL | 2011-03-24 |
| 1921 | SUPPL | 2011-03-24 |
| 1922 | SUPPL | 2010-11-02 |
| 34188 | SUPPL | 2010-10-28 |
| 1920 | SUPPL | 2009-11-19 |
| 12144 | SUPPL | 2009-11-05 |
| 34187 | SUPPL | 2009-02-04 |
| 21055 | SUPPL | 2009-02-03 |
| 12145 | SUPPL | 2008-11-07 |
| 21054 | SUPPL | 2008-11-03 |
| 1918 | SUPPL | 2007-08-07 |
| 12143 | SUPPL | 2007-08-03 |
| 41124 | SUPPL | 2007-07-09 |
| 41123 | SUPPL | 2007-07-09 |
| 41122 | SUPPL | 2007-07-09 |
| 20454 | SUPPL | 2007-07-09 |
| 20453 | SUPPL | 2007-07-09 |
| 19951 | SUPPL | 2006-09-25 |
| 19950 | SUPPL | 2006-09-25 |
| 19947 | SUPPL | 2006-09-25 |
| 19946 | SUPPL | 2006-03-23 |
| 19949 | SUPPL | 2006-02-08 |
| 19948 | SUPPL | 2006-02-08 |
| 1917 | SUPPL | 2006-02-08 |
| 44042 | ORIG | 2005-08-16 |
| 1915 | SUPPL | 2005-07-15 |
| 19945 | SUPPL | 2005-01-13 |
| 12142 | SUPPL | 2005-01-13 |
| 20455 | SUPPL | 2004-09-15 |
| 20452 | SUPPL | 2004-06-29 |
| 1916 | SUPPL | 2004-05-27 |
| 19944 | SUPPL | 2004-04-20 |
| 19943 | SUPPL | 2004-04-20 |
| 34184 | SUPPL | 2003-04-24 |
| 19942 | SUPPL | 2002-10-02 |
| 34185 | SUPPL | 2001-12-14 |
| 19941 | SUPPL | 2001-12-14 |
| 19940 | SUPPL | 2001-04-13 |
| 12141 | SUPPL | 2001-04-13 |
| 1914 | SUPPL | 1999-05-11 |
| 53124 | ORIG | 1900-01-01 |
| 53123 | ORIG | 1900-01-01 |
| 53122 | ORIG | 1900-01-01 |
| 53121 | ORIG | 1900-01-01 |