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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077670-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077670-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077670-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077670-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077670-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077670-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077670-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077670-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077670-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077670-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077670-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077670-001 | AB | 1 | 8072bd15b7f6… |
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 | Preferred Pharmaceuticals Inc. | f6346a11-88b9-4425-b08d-a22f19c4ceb4 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 55f514c6-f6ec-13ac-e063-6294a90ac957 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Major Pharmaceuticals | 4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 0904-6924 0904-6926 0904-6925 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | REMEDYREPACK INC. | cac718b8-64bc-4aca-9b22-f2b00077bd41 | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | REMEDYREPACK INC. | 268bd7f7-bc17-4850-ab7c-1b73caa564d5 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Coupler LLC | 4f94a6d7-8719-834c-e063-6294a90a3448 | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | 6c26a87a-b2b6-4302-bb8d-2031461f28ce | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | ddbf623f-8b6f-4e8d-87d3-dc890c0ab875 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | REMEDYREPACK INC. | bdbcb3ce-e424-43eb-9f1a-77eda4dfbdaa | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline | SERTRALINE | REMEDYREPACK INC. | c614be38-cb45-44a1-b78e-0cdfc0691618 | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline | SERTRALINE | REMEDYREPACK INC. | f515d1e7-5803-4797-b3cc-8dbea85d96e5 | 2026-03-17 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline | SERTRALINE | REMEDYREPACK INC. | e1864a7e-44b9-4399-9554-0c18b46fbdd6 | 2026-03-17 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | b5e98b93-d8f8-4eed-8a0a-63b347b670ed | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 5f0616f6-433f-45c9-86f4-f802fda5d891 | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | fd92c8d3-17ec-477c-bc25-e5239c8606ac | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline | SERTRALINE | AvPAK | 10baaffd-061e-d665-e063-6294a90a1594 | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Cardinal Health 107, LLC | fd8a815e-88b7-4bef-9e32-6dbc735711a3 | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 55154-3570 55154-3569 |
| Sertraline | SERTRALINE | REMEDYREPACK INC. | 84aba223-04ae-479c-b5dd-e04fab45045d | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 70518-0153 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 345271ff-6a48-4888-a8d0-5a8ad60c7a21 | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 0de9e3e3-912a-428b-89d2-70811a56cdc5 | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | 077670 ANDA077670 |
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 |