Application 077584
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA
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 |
|---|---|---|---|---|---|---|---|
| A077584-001 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | |
| A077584-002 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | |
| A077584-003 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | |
| A077584-004 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077584-001 | AB |
| A077584-002 | AB |
| A077584-003 | AB |
| A077584-004 | 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 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077584-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077584-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077584-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077584-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A077584-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077584-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077584-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077584-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077584-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077584-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077584-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077584-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077584-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077584-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077584-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077584-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077584-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077584-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077584-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077584-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077584-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077584-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077584-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077584-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077584-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077584-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077584-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077584-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077584-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077584-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077584-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077584-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077584-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077584-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077584-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077584-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077584-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077584-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077584-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077584-004 | 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 | Coupler LLC | 598ece4d-0ac4-993b-e063-6294a90a1d34 | 2026-08-21 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | Coupler LLC | 598efb76-93ef-f7de-e063-6394a90a632e | 2026-08-21 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | Preferred Pharmaceuticals Inc. | 7d558598-6905-46da-8f34-668456c68411 | 2026-08-12 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | Preferred Pharmaceuticals Inc. | ee38b589-e646-4203-bea5-cc3744fe17c3 | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc | 605c1d23-c97c-4ea4-92d0-fed351de9d2e | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 68788-0797 |
| Paroxetine | PAROXETINE | REMEDYREPACK INC. | 05ec70fd-4c65-495f-ba12-e8433a10b655 | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | REMEDYREPACK INC. | c002508e-f96c-413b-b232-5d55fceeffe0 | 2026-08-07 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | REMEDYREPACK INC. | 679e4b9b-0f7b-450a-aca7-1b448cccbeed | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | HAWAII REPACK, INC. | d5206418-aa7f-42dd-b977-4b9d1e4b2752 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | American Health Packaging | b5a8f864-a53d-48d9-aca6-6b64017fb168 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 68084-044 68084-046 68084-047 68084-045 |
| PAROXETINE | PAROXETINE | DIRECT RX | 2cfe30fc-9c46-4efd-e054-00144ff8d46c | 2026-03-05 | Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | A-S Medication Solutions | 31e4bb7c-59ab-4cbf-ba08-317c1417b28f | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | A-S Medication Solutions | a809a6b5-18a3-4771-aaf8-7197d1743540 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | NuCare Pharamceuticals, Inc. | 49dc055c-faef-0be3-e063-6394a90a934f | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | PD-Rx Pharmaceuticals, Inc. | c0acc97d-3d8d-4a7f-8acd-99050b0af2f1 | 2025-10-20 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | Bryant Ranch Prepack | 0a0f8897-2099-4038-9b96-ed9c4f084018 | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | Bryant Ranch Prepack | 7a702760-9b72-4595-bf47-01aff786c74d | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | Bryant Ranch Prepack | 07f245c5-fcb0-3008-d69e-10290cadbfa6 | 2025-03-21 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | Asclemed USA, Inc. | 4acd3e7a-4f19-4428-9452-48ce370cb3db | 2025-02-13 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | Direct_Rx | fea936a5-fdeb-e4fb-e053-6294a90a8995 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
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 |
|---|---|---|---|---|---|
| 65084-963 | Paroxetine | Paroxetine | McKesson Corporation dba RX Pak | ANDA | Current |
| 65841-097 | Paroxetine | Paroxetine Hydrochloride | Zydus Lifesciences Limited | ANDA | Current |
| 65841-097 | Paroxetine | Paroxetine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-097 | Paroxetine | Paroxetine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-097 | Paroxetine | Paroxetine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-097 | Paroxetine | Paroxetine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-098 | Paroxetine | Paroxetine Hydrochloride | Zydus Lifesciences Limited | ANDA | Current |
| 65841-098 | Paroxetine | Paroxetine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-098 | Paroxetine | Paroxetine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-098 | Paroxetine | Paroxetine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-098 | Paroxetine | Paroxetine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-099 | Paroxetine | Paroxetine Hydrochloride | Zydus Lifesciences Limited | ANDA | Current |
| 65841-099 | Paroxetine | Paroxetine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-099 | Paroxetine | Paroxetine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-099 | Paroxetine | Paroxetine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-099 | Paroxetine | Paroxetine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-601 | Paroxetine | Paroxetine Hydrochloride | Zydus Lifesciences Limited | ANDA | Current |
| 65841-601 | Paroxetine | Paroxetine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-601 | Paroxetine | Paroxetine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-601 | Paroxetine | Paroxetine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-601 | Paroxetine | Paroxetine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 66267-721 | Paroxetine | Paroxetine | NuCare Pharmaceuticals,In | ANDA | Current |
| 66267-721 | Paroxetine | Paroxetine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 66267-721 | Paroxetine | Paroxetine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 67046-530 | Paroxetine | Paroxetine hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-531 | Paroxetine | Paroxetine hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-532 | Paroxetine | Paroxetine hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-533 | Paroxetine | Paroxetine hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 68071-1594 | Paroxetine | Paroxetine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-1594 | Paroxetine | Paroxetine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-1594 | Paroxetine | Paroxetine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-1740 | Paroxetine | Paroxetine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1740 | Paroxetine | Paroxetine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1740 | Paroxetine | Paroxetine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1740 | Paroxetine | Paroxetine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1746 | Paroxetine | Paroxetine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1746 | Paroxetine | Paroxetine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4997 | Paroxetine | Paroxetine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4997 | Paroxetine | Paroxetine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68084-044 | Paroxetine | Paroxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-044 | Paroxetine | Paroxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-044 | Paroxetine | Paroxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-044 | Paroxetine | Paroxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-045 | Paroxetine | Paroxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-045 | Paroxetine | Paroxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-045 | Paroxetine | Paroxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-045 | Paroxetine | Paroxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-046 | Paroxetine | Paroxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-046 | Paroxetine | Paroxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-046 | Paroxetine | Paroxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-046 | Paroxetine | Paroxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-047 | Paroxetine | Paroxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-047 | Paroxetine | Paroxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-047 | Paroxetine | Paroxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-047 | Paroxetine | Paroxetine Hydrochloride | American Health Packaging | ANDA | Current |
| 68382-001 | Paroxetine | Paroxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-001 | Paroxetine | Paroxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-001 | Paroxetine | Paroxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-001 | Paroxetine | Paroxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-001 | Paroxetine | Paroxetine | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-001 | Paroxetine | Paroxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-097 | Paroxetine | Paroxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-097 | Paroxetine | Paroxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-097 | Paroxetine | Paroxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-097 | Paroxetine | Paroxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-097 | Paroxetine | Paroxetine | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-097 | Paroxetine | Paroxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-098 | Paroxetine | Paroxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-098 | Paroxetine | Paroxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-098 | Paroxetine | Paroxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-098 | Paroxetine | Paroxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-098 | Paroxetine | Paroxetine | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-098 | Paroxetine | Paroxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-099 | Paroxetine | Paroxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-099 | Paroxetine | Paroxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-099 | Paroxetine | Paroxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-099 | Paroxetine | Paroxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-099 | Paroxetine | Paroxetine | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-099 | Paroxetine | Paroxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68788-0797 | Paroxetine | Paroxetine Hydrochloride | Preferred Pharmaceuticals, Inc | ANDA | Current |