Application 078406
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA
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 |
|---|---|---|---|---|---|---|---|
| A078406-001 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | |
| A078406-002 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | |
| A078406-003 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | |
| A078406-004 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078406-001 | AB |
| A078406-002 | AB |
| A078406-003 | AB |
| A078406-004 | 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 | A078406-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078406-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078406-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078406-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078406-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078406-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078406-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078406-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078406-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078406-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078406-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078406-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078406-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078406-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078406-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078406-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078406-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078406-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078406-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078406-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078406-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078406-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078406-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078406-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078406-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078406-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078406-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078406-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078406-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078406-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078406-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078406-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078406-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078406-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078406-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078406-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078406-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078406-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078406-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078406-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 | 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 | A078406-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078406-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078406-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078406-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078406-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078406-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078406-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078406-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078406-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078406-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078406-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078406-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078406-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078406-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078406-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078406-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078406-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078406-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078406-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078406-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078406-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078406-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078406-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078406-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078406-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078406-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078406-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078406-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078406-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078406-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078406-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078406-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078406-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078406-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078406-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078406-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078406-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078406-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078406-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078406-004 | 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. | f52ca1fc-fbf7-4b2b-9e74-975c310b8ce6 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | 078406 ANDA078406 |
| Paroxetine | PAROXETINE HYDROCHLORIDE | NorthStar Rx LLC | 118320de-0632-4139-8b13-7428b41da0ac | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | 078406 ANDA078406 16714-183 16714-181 16714-182 16714-184 |
| Paroxetine | PAROXETINE | AvPAK | d9a5e0aa-e638-5d6e-75c2-20cb78fc4f43 | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | 078406 ANDA078406 50268-643 50268-640 50268-642 50268-641 |
| Paroxetine | PAROXETINE | Aurolife Pharma LLC | e1ea4019-bb66-403c-a3d5-6ae056a59116 | 2025-06-07 | Boxed warning, Warnings, Adverse reactions | 078406 ANDA078406 13107-155 13107-156 13107-154 13107-157 |
| Paroxetine | PAROXETINE HYDROCHLORIDE | Aurobindo Pharma Limited | 326e8ab0-6886-4749-9544-885b37070051 | 2025-05-15 | Boxed warning, Warnings, Adverse reactions | 078406 ANDA078406 65862-155 65862-154 65862-156 |
| Paroxetine | PAROXETINE | NCS HealthCare of KY, LLC dba Vangard Labs | 0a8a58c7-5008-4c65-ae0e-e4ee809b1807 | 2022-09-02 | Boxed warning, Warnings, Adverse reactions | 078406 ANDA078406 0615-8359 |
| Paroxetine | PAROXETINE | Proficient Rx LP | 847118ec-c139-466c-834b-1ae0b6e1f791 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | 078406 ANDA078406 63187-564 |
| Paroxetine | PAROXETINE | Aphena Pharma Solutions - Tennessee, LLC | 662223ec-3b9b-4a85-9680-789522363a7b | 2018-07-26 | Boxed warning, Warnings, Adverse reactions | 078406 ANDA078406 43353-713 |
| Paroxetine | PAROXETINE | Aphena Pharma Solutions - Tennessee, LLC | 30fd2fc4-f661-44c9-a9a9-9d0de0892e3c | 2018-05-08 | Boxed warning, Warnings, Adverse reactions | 078406 ANDA078406 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-8359 | Paroxetine | Paroxetine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8359 | Paroxetine | Paroxetine | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 13107-154 | Paroxetine | Paroxetine | Aurolife Pharma LLC | ANDA | Current |
| 13107-154 | Paroxetine | Paroxetine | Aurolife Pharma, LLC | ANDA | Current |
| 13107-154 | Paroxetine | Paroxetine | Aurolife Pharma, LLC | ANDA | Current |
| 13107-154 | Paroxetine | Paroxetine | Aurolife Pharma LLC | ANDA | Current |
| 13107-154 | Paroxetine | Paroxetine | Aurolife Pharma LLC | ANDA | Current |
| 13107-155 | Paroxetine | Paroxetine | Aurolife Pharma LLC | ANDA | Current |
| 13107-155 | Paroxetine | Paroxetine | Aurolife Pharma, LLC | ANDA | Current |
| 13107-155 | Paroxetine | Paroxetine | Aurolife Pharma, LLC | ANDA | Current |
| 13107-155 | Paroxetine | Paroxetine | Aurolife Pharma LLC | ANDA | Current |
| 13107-155 | Paroxetine | Paroxetine | Aurolife Pharma LLC | ANDA | Current |
| 13107-156 | Paroxetine | Paroxetine | Aurolife Pharma LLC | ANDA | Current |
| 13107-156 | Paroxetine | Paroxetine | Aurolife Pharma, LLC | ANDA | Current |
| 13107-156 | Paroxetine | Paroxetine | Aurolife Pharma, LLC | ANDA | Current |
| 13107-156 | Paroxetine | Paroxetine | Aurolife Pharma LLC | ANDA | Current |
| 13107-156 | Paroxetine | Paroxetine | Aurolife Pharma LLC | ANDA | Current |
| 13107-157 | Paroxetine | Paroxetine | Aurolife Pharma LLC | ANDA | Current |
| 13107-157 | Paroxetine | Paroxetine | Aurolife Pharma, LLC | ANDA | Current |
| 13107-157 | Paroxetine | Paroxetine | Aurolife Pharma, LLC | ANDA | Current |
| 13107-157 | Paroxetine | Paroxetine | Aurolife Pharma LLC | ANDA | Current |
| 13107-157 | Paroxetine | Paroxetine | Aurolife Pharma LLC | ANDA | Current |
| 16714-181 | Paroxetine | Paroxetine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-182 | Paroxetine | Paroxetine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-183 | Paroxetine | Paroxetine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-184 | Paroxetine | Paroxetine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 35356-892 | Paroxetine | Paroxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 43353-713 | Paroxetine | Paroxetine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-845 | Paroxetine | Paroxetine Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-994 | Paroxetine | Paroxetine Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-0848 | Paroxetine | Paroxetine | A-S Medication Solutions | ANDA | Current |
| 50090-0848 | Paroxetine | Paroxetine | A-S Medication Solutions | ANDA | Current |
| 50090-0921 | Paroxetine | Paroxetine | A-S Medication Solutions | ANDA | Current |
| 50090-2143 | Paroxetine | Paroxetine | A-S Medication Solutions | ANDA | Current |
| 50090-2143 | Paroxetine | Paroxetine | A-S Medication Solutions | ANDA | Current |
| 50268-640 | Paroxetine | Paroxetine | AvPAK | ANDA | Current |
| 50268-640 | Paroxetine | Paroxetine | AvPAK | ANDA | Current |
| 50268-640 | Paroxetine | Paroxetine | AvPAK | ANDA | Current |
| 50268-640 | Paroxetine | Paroxetine | AvPAK | ANDA | Current |
| 50268-640 | Paroxetine | Paroxetine | AvPAK | ANDA | Current |
| 50268-640 | Paroxetine | Paroxetine | AvPAK | ANDA | Current |
| 50268-641 | Paroxetine | Paroxetine | AvPAK | ANDA | Current |
| 50268-642 | Paroxetine | Paroxetine | AvPAK | ANDA | Current |
| 50268-642 | Paroxetine | Paroxetine | AvPAK | ANDA | Current |
| 50268-642 | Paroxetine | Paroxetine | AvPAK | ANDA | Current |
| 50268-642 | Paroxetine | Paroxetine | AvPAK | ANDA | Current |
| 50268-642 | Paroxetine | Paroxetine | AvPAK | ANDA | Current |
| 50268-642 | Paroxetine | Paroxetine | AvPAK | ANDA | Current |
| 50268-643 | Paroxetine | Paroxetine | AvPAK | ANDA | Current |
| 50268-643 | Paroxetine | Paroxetine | AvPAK | ANDA | Current |
| 50268-643 | Paroxetine | Paroxetine | AvPAK | ANDA | Current |
| 50268-643 | Paroxetine | Paroxetine | AvPAK | ANDA | Current |
| 50268-643 | Paroxetine | Paroxetine | AvPAK | ANDA | Current |
| 50268-643 | Paroxetine | Paroxetine | AvPAK | ANDA | Current |
| 52343-073 | Paroxetine | Paroxetine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-073 | Paroxetine | Paroxetine Hydrochloride | LUCID PHARMA LLC | ANDA | Current |
| 52343-074 | Paroxetine | Paroxetine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-074 | Paroxetine | Paroxetine Hydrochloride | LUCID PHARMA LLC | ANDA | Current |
| 52343-075 | Paroxetine | Paroxetine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-075 | Paroxetine | Paroxetine Hydrochloride | LUCID PHARMA LLC | ANDA | Current |
| 52343-076 | Paroxetine | Paroxetine Hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-076 | Paroxetine | Paroxetine Hydrochloride | LUCID PHARMA LLC | ANDA | Current |
| 53808-0749 | Paroxetine | PAROXETINE HYDROCHLORIDE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0752 | Paroxetine | PAROXETINE HYDROCHLORIDE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0756 | Paroxetine | PAROXETINE HYDROCHLORIDE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55700-040 | Paroxetine | Paroxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 63187-564 | Paroxetine | Paroxetine | Proficient Rx LP | ANDA | Current |
| 63187-564 | Paroxetine | Paroxetine | Proficient Rx LP | ANDA | Current |
| 65862-154 | Paroxetine | Paroxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-154 | Paroxetine | Paroxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-154 | Paroxetine | Paroxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-154 | Paroxetine | Paroxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-155 | Paroxetine | Paroxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-155 | Paroxetine | Paroxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-155 | Paroxetine | Paroxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-155 | Paroxetine | Paroxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-156 | Paroxetine | Paroxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-156 | Paroxetine | Paroxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-156 | Paroxetine | Paroxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-156 | Paroxetine | Paroxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23905 | ORIG | 2007-08-16 |