Application 077670
- Type
- ANDA
- Sponsor
- LUPIN
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 |
|---|---|---|---|---|---|---|---|
| A077670-001 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | |
| A077670-002 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | |
| A077670-003 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077670-001 | AB |
| A077670-002 | AB |
| A077670-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077670-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077670-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077670-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A077670-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077670-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077670-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077670-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077670-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077670-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077670-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077670-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077670-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077670-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077670-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077670-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077670-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077670-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077670-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077670-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077670-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077670-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077670-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077670-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077670-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077670-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077670-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077670-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077670-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077670-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077670-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077670-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077670-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077670-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077670-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077670-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077670-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077670-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077670-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077670-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077670-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077670-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077670-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077670-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A077670-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077670-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077670-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077670-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077670-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077670-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077670-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077670-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077670-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077670-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077670-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077670-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077670-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077670-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077670-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077670-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077670-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077670-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077670-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077670-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077670-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077670-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077670-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077670-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077670-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077670-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077670-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077670-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077670-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077670-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077670-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077670-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077670-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077670-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077670-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077670-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077670-001 | AB | 1 | 301d65b070ca… |
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 | A-S Medication Solutions | 1b069fd8-26b9-459e-abfb-de28c012ddcb | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | a06f2cf6-ccef-47bf-aba8-a42bada46d8b | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 473d6055-b811-4ffb-9398-88f50a152196 | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | 42120ff8-b353-4632-9ea9-54de9a698724 | 2025-10-14 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 68180-353 68180-352 68180-351 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | AvPAK | 40be43b2-649b-0928-e063-6394a90a3b48 | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline | SERTRALINE | NuCare Pharmaceuticals,Inc. | 0a1f7d44-c339-a4dd-e063-6294a90ac0de | 2025-02-03 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline | SERTRALINE | Quality Care Products, LLC | 6ed2b9b7-e4af-4e28-a7d5-4ccb514af217 | 2024-12-17 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 55700-225 |
| Sertraline | SERTRALINE | A-S Medication Solutions | e93391c9-db88-4fa5-b1d5-f6c6de78b31c | 2024-10-23 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline | SERTRALINE | A-S Medication Solutions | f5bf9595-d9f9-40b1-9b3b-da277fd5ab7f | 2024-10-16 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline | SERTRALINE | A-S Medication Solutions | b2533b60-cc54-4905-a4ee-ea08a160f8c6 | 2024-10-16 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 50090-0991 |
| Sertraline | SERTRALINE | A-S Medication Solutions | cbc2bd3b-03fc-47b9-91d1-8989ec90c7e6 | 2024-08-30 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 50090-5848 |
| Sertraline | SERTRALINE | NuCare Pharmaceuticals,Inc. | 1ac8a624-2292-b7b8-e063-6394a90a165b | 2024-06-13 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline | SERTRALINE | Proficient Rx LP | 35dea1a2-ec26-4e52-8f09-ee4678e77946 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 63187-055 63187-478 63187-212 |
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 |
|---|---|---|---|---|---|
| 0615-7989 | Sertraline | Sertraline | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-7989 | Sertraline | Sertraline | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7989 | Sertraline | Sertraline | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7990 | Sertraline | Sertraline | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-7990 | Sertraline | Sertraline | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7990 | Sertraline | Sertraline | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7991 | Sertraline | Sertraline | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-7991 | Sertraline | Sertraline | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7991 | Sertraline | Sertraline | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-6924 | Sertraline | Sertraline | Major Pharmaceuticals | ANDA | Current |
| 0904-6925 | Sertraline | Sertraline | Major Pharmaceuticals | ANDA | Current |
| 0904-6926 | Sertraline | Sertraline | Major Pharmaceuticals | ANDA | Current |
| 33261-346 | Sertraline | Sertraline | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 35356-832 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 42708-068 | Sertraline | Sertraline | QPharma Inc | ANDA | Current |
| 42708-068 | Sertraline | Sertraline | QPharma Inc | ANDA | Current |
| 50090-0989 | Sertraline | Sertraline | A-S Medication Solutions | ANDA | Current |
| 50090-0989 | Sertraline | Sertraline | A-S Medication Solutions | ANDA | Current |
| 50090-0991 | Sertraline | Sertraline | A-S Medication Solutions | ANDA | Current |
| 50090-5848 | Sertraline | Sertraline | A-S Medication Solutions | ANDA | Current |
| 50436-3520 | Sertraline | Sertraline | Unit Dose Services | ANDA | Current |
| 51655-352 | Sertraline | Sertraline | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 51655-979 | Sertraline | Sertraline | Northwind Pharmaceuticals | ANDA | Current |
| 53217-380 | Sertraline | Sertraline | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53808-0586 | SERTRALINE HYDROCHLORIDE | sertraline hydrochloride | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-3569 | Sertraline | Sertraline | Cardinal Health 107, LLC | ANDA | Current |
| 55154-3570 | Sertraline | Sertraline | Cardinal Health 107, LLC | ANDA | Current |
| 55700-222 | Sertraline | Sertraline | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-225 | Sertraline | Sertraline | Quality Care Products, LLC | ANDA | Current |
| 57297-351 | Sertraline | Sertraline | LUPIN LIMITED | ANDA | Current |
| 57297-352 | Sertraline | Sertraline | LUPIN LIMITED | ANDA | Current |
| 57297-353 | Sertraline | Sertraline | LUPIN LIMITED | ANDA | Current |
| 63187-055 | Sertraline | Sertraline | Proficient Rx LP | ANDA | Current |
| 63187-055 | Sertraline | Sertraline | Proficient Rx LP | ANDA | Current |
| 63187-055 | Sertraline | Sertraline | Proficient Rx LP | ANDA | Current |
| 63187-212 | Sertraline | Sertraline | Proficient Rx LP | ANDA | Current |
| 63187-212 | Sertraline | Sertraline | Proficient Rx LP | ANDA | Current |
| 63187-212 | Sertraline | Sertraline | Proficient Rx LP | ANDA | Current |
| 63187-478 | Sertraline | Sertraline | Proficient Rx LP | ANDA | Current |
| 63187-478 | Sertraline | Sertraline | Proficient Rx LP | ANDA | Current |
| 63187-478 | Sertraline | Sertraline | Proficient Rx LP | ANDA | Current |
| 64725-0351 | Sertraline | Sertraline | TYA Pharmaceuticals | ANDA | Current |
| 67046-668 | Sertraline | Sertraline | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-1199 | Sertraline | Sertraline | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1199 | Sertraline | Sertraline | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1199 | Sertraline | Sertraline | RedPharm Drug, Inc. | ANDA | Current |
| 68071-4400 | Sertraline | Sertraline | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4400 | Sertraline | Sertraline | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4400 | Sertraline | Sertraline | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4400 | Sertraline | Sertraline | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68180-351 | Sertraline | Sertraline | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-351 | Sertraline | Sertraline | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-351 | Sertraline | Sertraline | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-351 | Sertraline | Sertraline | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-351 | Sertraline | Sertraline | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-352 | Sertraline | Sertraline | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-352 | Sertraline | Sertraline | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-352 | Sertraline | Sertraline | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-352 | Sertraline | Sertraline | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-352 | Sertraline | Sertraline | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-353 | Sertraline | Sertraline | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-353 | Sertraline | Sertraline | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-353 | Sertraline | Sertraline | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-353 | Sertraline | Sertraline | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-353 | Sertraline | Sertraline | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68645-589 | Sertraline | Sertraline | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-589 | Sertraline | Sertraline | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68788-7329 | Sertraline | Sertraline | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7329 | Sertraline | Sertraline | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7329 | Sertraline | Sertraline | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0153 | Sertraline | Sertraline | REMEDYREPACK INC. | ANDA | Current |
| 70518-0153 | Sertraline | Sertraline | REMEDYREPACK INC. | ANDA | Current |
| 70518-0153 | Sertraline | Sertraline | REMEDYREPACK INC. | ANDA | Current |
| 70518-0153 | Sertraline | Sertraline | REMEDYREPACK INC. | ANDA | Current |
| 70518-0153 | Sertraline | Sertraline | REMEDYREPACK INC. | ANDA | Current |
| 70518-0153 | Sertraline | Sertraline | REMEDYREPACK INC. | ANDA | Current |
| 70518-0153 | Sertraline | Sertraline | REMEDYREPACK INC. | ANDA | Current |
| 70518-0153 | Sertraline | Sertraline | REMEDYREPACK INC. | ANDA | Current |
| 70518-0201 | Sertraline | Sertraline | REMEDYREPACK INC. | ANDA | Current |
| 70518-0201 | Sertraline | Sertraline | REMEDYREPACK INC. | ANDA | Current |