Application 202825
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 25MG BASE | No | No |
| 002 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 50MG BASE | No | No |
| 003 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 100MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202825-001 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2014-11-07 | |
| A202825-002 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2014-11-07 | |
| A202825-003 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2014-11-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202825-001 | AB |
| A202825-002 | AB |
| A202825-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A202825-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2014-11-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202825-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2014-11-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202825-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2014-11-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202825-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2014-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202825-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2014-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202825-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2014-11-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202825-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2014-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202825-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2014-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202825-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2014-11-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202825-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2014-11-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202825-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2014-11-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202825-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2014-11-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202825-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2014-11-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202825-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2014-11-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202825-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2014-11-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202825-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2014-11-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202825-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2014-11-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202825-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2014-11-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202825-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2014-11-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202825-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2014-11-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202825-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2014-11-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202825-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2014-11-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202825-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2014-11-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202825-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2014-11-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202825-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2014-11-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202825-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2014-11-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202825-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2014-11-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202825-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2014-11-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202825-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2014-11-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202825-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2014-11-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202825-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2014-11-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202825-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2014-11-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202825-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2014-11-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202825-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2014-11-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202825-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2014-11-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202825-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2014-11-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202825-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2014-11-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202825-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2014-11-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202825-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2014-11-07 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202825-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2014-11-07 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A202825-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202825-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202825-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202825-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202825-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202825-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202825-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202825-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202825-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202825-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202825-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202825-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202825-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202825-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202825-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202825-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202825-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202825-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202825-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202825-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202825-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202825-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202825-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202825-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202825-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202825-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202825-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202825-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202825-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202825-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202825-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202825-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202825-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202825-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202825-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202825-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202825-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202825-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202825-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202825-001 | AB | 1 | 1e350fbaab3a… |
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 |
|---|---|---|---|---|---|---|
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | e919f195-0ce1-4d71-9883-efec05b9a050 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | 202825 ANDA202825 |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 730448bf-2d78-44a4-e053-2991aa0ada9e | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | 202825 ANDA202825 60760-738 |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | 5e91adad-9757-49e4-a3f1-1db0ef396416 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 202825 ANDA202825 |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | aa13261f-46a7-4381-8084-b3ad46221e2f | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 202825 ANDA202825 43063-855 |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Accord Healthcare, Inc. | 205ecf52-8138-44a7-ad9a-b3aa7f4fa11a | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | 202825 ANDA202825 16729-217 16729-216 16729-215 |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | QPharma, Inc. | dc97a895-8c2f-4891-85f3-7f45e2396140 | 2025-12-15 | Boxed warning, Warnings, Adverse reactions | 202825 ANDA202825 42708-092 |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 2beb45ca-0ebb-4908-807a-7413250693e3 | 2025-09-19 | Boxed warning, Warnings, Adverse reactions | 202825 ANDA202825 68788-8210 |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | 82a44e20-d0ee-4ed7-9234-24ef4496ac1d | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 202825 ANDA202825 |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 14c4fa96-8919-4ea7-ad72-129f288d8cfc | 2023-05-10 | Boxed warning, Warnings, Adverse reactions | 202825 ANDA202825 50090-3203 |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 68c94fb4-3018-44af-b982-2b4b6d461e6f | 2022-06-24 | Boxed warning, Warnings, Adverse reactions | 202825 ANDA202825 |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Proficient Rx LP | 6b532e6a-b040-4a10-a242-fb6d8dfc0852 | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | 202825 ANDA202825 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16729-215 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-215 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-215 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-215 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-216 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-216 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-216 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-216 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-217 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-217 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-217 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-217 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Accord Healthcare, Inc. | ANDA | Current |
| 42708-092 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | QPharma Inc | ANDA | Current |
| 42708-092 | Sertraline Hydrochloride | Sertraline Hydrochloride | QPharma Inc | ANDA | Current |
| 42708-092 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | QPharma Inc | ANDA | Current |
| 43063-855 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-855 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-855 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-855 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-855 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-3203 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-3203 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-3203 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-3203 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-3945 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-3945 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-3945 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-3945 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-3945 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-3947 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-3947 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-3947 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-3947 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50436-0215 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Unit Dose Services | ANDA | Current |
| 50436-0215 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Unit Dose Services | ANDA | Current |
| 50436-0216 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Unit Dose Services | ANDA | Current |
| 50436-0216 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Unit Dose Services | ANDA | Current |
| 50436-0217 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Unit Dose Services | ANDA | Current |
| 50436-0217 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Unit Dose Services | ANDA | Current |
| 53002-4215 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-910 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Quality Care Products, LLC | ANDA | Current |
| 55700-910 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Quality Care Products, LLC | ANDA | Current |
| 55700-948 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Quality Care Products, LLC | ANDA | Current |
| 55700-948 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Quality Care Products, LLC | ANDA | Current |
| 55700-948 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Quality Care Products, LLC | ANDA | Current |
| 55700-977 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Quality Care Products, LLC | ANDA | Current |
| 60760-737 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-737 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-737 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-738 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-738 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-738 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-345 | Sertraline Hydrochloride | Sertraline Hydrochloride | Direct Rx | ANDA | Current |
| 61919-345 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-345 | Sertraline Hydrochloride | Sertraline Hydrochloride | Direct_Rx | ANDA | Current |
| 61919-345 | Sertraline Hydrochloride | Sertraline Hydrochloride | Direct_Rx | ANDA | Current |
| 61919-345 | Sertraline Hydrochloride | Sertraline Hydrochloride | Direct Rx | ANDA | Current |
| 61919-345 | Sertraline Hydrochloride | Sertraline Hydrochloride | Direct_Rx | ANDA | Current |
| 61919-345 | Sertraline Hydrochloride | Sertraline Hydrochloride | Direct Rx | ANDA | Current |
| 68071-2496 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3309 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3309 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3379 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4029 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4029 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4029 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4750 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4750 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7001 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7001 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7035 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7035 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7035 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7928 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7928 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8109 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8109 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8210 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-1615 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1615 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |