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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077584-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077584-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077584-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077584-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077584-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077584-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077584-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077584-004 | AB | 1 | d06236e962d9… |
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 | 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 |
| Paroxetine | PAROXETINE | REMEDYREPACK INC. | 05ec70fd-4c65-495f-ba12-e8433a10b655 | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | REMEDYREPACK INC. | c002508e-f96c-413b-b232-5d55fceeffe0 | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | REMEDYREPACK INC. | bc0efd3b-c6b9-4ed0-b517-6e57e4700b7b | 2026-03-11 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| PAROXETINE | PAROXETINE | DIRECT RX | 2cfe30fc-9c46-4efd-e054-00144ff8d46c | 2026-03-05 | Warnings, Adverse reactions | 077584 ANDA077584 61919-513 |
| 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 55289-972 |
| Paroxetine | PAROXETINE | Preferred Pharmaceuticals Inc. | 7d558598-6905-46da-8f34-668456c68411 | 2025-09-08 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc | 605c1d23-c97c-4ea4-92d0-fed351de9d2e | 2025-09-05 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | Preferred Pharmaceuticals Inc. | ee38b589-e646-4203-bea5-cc3744fe17c3 | 2025-09-05 | 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 63629-3349 |
| 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 |
| Paroxetine | PAROXETINE | Zydus Pharmaceuticals USA Inc. | a6bb4f0a-1555-4550-a7a4-99609674b1e7 | 2025-01-07 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-5576 | Paroxetine | Paroxetine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-5577 | Paroxetine | Paroxetine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-5578 | Paroxetine | Paroxetine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-5579 | Paroxetine | Paroxetine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 21695-101 | Paroxetine | Paroxetine Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 21695-103 | Paroxetine | Paroxetine Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 21695-104 | Paroxetine | Paroxetine Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 33261-090 | Paroxetine | Paroxetine | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-091 | Paroxetine | Paroxetine | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 49999-632 | PAROXETINE | Paroxetine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-632 | PAROXETINE | Paroxetine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-828 | Paroxetine | Paroxetine Hydrochloride | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | ANDA | Current |
| 50436-3933 | Paroxetine | Paroxetine | Unit Dose Services | ANDA | Current |
| 51655-356 | Paroxetine | Paroxetine | Northwind Pharmaceuticals | ANDA | Current |
| 51655-356 | Paroxetine | Paroxetine | Northwind Pharmaceuticals | ANDA | Current |
| 52959-775 | Paroxetine | Paroxetine Hydrochloride | H.J. Harkins Company, Inc. | ANDA | Current |
| 52959-776 | Paroxetine | Paroxetine Hydrochloride | H.J. Harkins Company, Inc. | ANDA | Current |
| 53002-1174 | Paroxetine | Paroxetine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1174 | Paroxetine | Paroxetine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53808-0682 | Paroxetine | Paroxetine Hydrochloride Hemihydrate | State of Florida DOH Central Pharmacy | ANDA | Current |
| 54458-988 | Paroxetine | Paroxetine hydrochloride | International Laboratories, LLC | ANDA | Current |
| 54458-988 | Paroxetine | Paroxetine hydrochloride | International Laboratories, LLC | ANDA | Current |
| 54458-989 | Paroxetine | Paroxetine hydrochloride | International Laboratories, LLC | ANDA | Current |
| 54458-989 | Paroxetine | Paroxetine hydrochloride | International Laboratories, LLC | ANDA | Current |
| 54458-990 | Paroxetine | Paroxetine hydrochloride | International Laboratories, LLC | ANDA | Current |
| 54458-990 | Paroxetine | Paroxetine hydrochloride | International Laboratories, LLC | ANDA | Current |
| 55154-4753 | Paroxetine | Paroxetine Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-4753 | Paroxetine | Paroxetine Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-6640 | Paroxetine | Paroxetine Hydrochloride | Cardinal Health | ANDA | Current |
| 55289-972 | Paroxetine | Paroxetine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-972 | Paroxetine | Paroxetine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-972 | Paroxetine | Paroxetine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-972 | Paroxetine | Paroxetine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-972 | Paroxetine | Paroxetine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-972 | Paroxetine | Paroxetine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-972 | Paroxetine | Paroxetine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-972 | Paroxetine | Paroxetine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-972 | Paroxetine | Paroxetine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 58118-0183 | Paroxetine | Paroxetine | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-0183 | Paroxetine | Paroxetine | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-0183 | Paroxetine | Paroxetine | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 60760-398 | Paroxetine | Paroxetine | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-501 | Paroxetine | Paroxetine | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-513 | PAROXETINE | PAROXETINE | DIRECT RX | ANDA | Current |
| 61919-596 | PAROXETINE | PAROXETINE | DirectRX | ANDA | Current |
| 61919-658 | PAROXETINE | PAROXETINE | DIRECT RX | ANDA | Current |
| 61919-658 | PAROXETINE | PAROXETINE | DIRECT RX | ANDA | Current |
| 61919-658 | PAROXETINE | PAROXETINE | DIRECT RX | ANDA | Current |
| 61919-658 | PAROXETINE | PAROXETINE | DIRECT RX | ANDA | Current |
| 61919-658 | PAROXETINE | PAROXETINE | DIRECT RX | ANDA | Current |
| 63187-105 | Paroxetine | Paroxetine | Proficient Rx LP | ANDA | Current |
| 63187-105 | Paroxetine | Paroxetine | Proficient Rx LP | ANDA | Current |
| 63187-190 | Paroxetine | Paroxetine | Proficient Rx LP | ANDA | Current |
| 63187-190 | Paroxetine | Paroxetine | Proficient Rx LP | ANDA | Current |
| 63187-434 | Paroxetine | Paroxetine | Proficient Rx LP | ANDA | Current |
| 63187-434 | Paroxetine | Paroxetine | Proficient Rx LP | ANDA | Current |
| 63629-1840 | Paroxetine | Paroxetine | Bryant Ranch Prepack | ANDA | Current |
| 63629-1840 | Paroxetine | Paroxetine | Bryant Ranch Prepack | ANDA | Current |
| 63629-3349 | Paroxetine | Paroxetine | Bryant Ranch Prepack | ANDA | Current |
| 63629-3349 | Paroxetine | Paroxetine | Bryant Ranch Prepack | ANDA | Current |
| 63629-3349 | Paroxetine | Paroxetine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8114 | Paroxetine | Paroxetine | Bryant Ranch Prepack | ANDA | Current |
| 63739-888 | Paroxetine | Paroxetine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-888 | Paroxetine | Paroxetine | McKesson Corporation | ANDA | Current |
| 63739-888 | Paroxetine | Paroxetine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-888 | Paroxetine | Paroxetine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-888 | Paroxetine | Paroxetine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-888 | Paroxetine | Paroxetine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-888 | Paroxetine | Paroxetine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-963 | Paroxetine | Paroxetine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-963 | Paroxetine | Paroxetine | McKesson Corporation | ANDA | Current |
| 63739-963 | Paroxetine | Paroxetine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-963 | Paroxetine | Paroxetine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-963 | Paroxetine | Paroxetine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-963 | Paroxetine | Paroxetine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-963 | Paroxetine | Paroxetine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 64725-0098 | Paroxetine | Paroxetine | TYA Pharmaceuticals | ANDA | Current |
| 64725-0197 | Paroxetine | Paroxetine | TYA Pharmaceuticals | ANDA | Current |
| 65084-888 | Paroxetine | Paroxetine | McKesson Corporation dba RX Pak | ANDA | Current |
| 65084-888 | Paroxetine | Paroxetine | McKesson Corporation dba RX Pak | ANDA | Current |