Application 077397
- Type
- ANDA
- Sponsor
- INVAGEN PHARMS
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 |
|---|---|---|---|---|---|---|---|
| A077397-001 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | |
| A077397-002 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | |
| A077397-003 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077397-001 | AB |
| A077397-002 | AB |
| A077397-003 | 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 | A077397-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077397-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077397-003 | 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 | A077397-001 | 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 | A077397-002 | 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 | A077397-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077397-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077397-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077397-003 | 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 | A077397-001 | 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 | A077397-002 | 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 | A077397-003 | 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 | A077397-001 | 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 | A077397-002 | 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 | A077397-003 | 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 | A077397-001 | 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 | A077397-002 | 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 | A077397-003 | 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 | A077397-001 | 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 | A077397-002 | 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 | A077397-003 | 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 | A077397-001 | 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 | A077397-002 | 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 | A077397-003 | 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 | A077397-001 | 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 | A077397-002 | 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 | A077397-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077397-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077397-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077397-003 | 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 | A077397-001 | 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 | A077397-002 | 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 | A077397-003 | 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 | A077397-001 | 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 | A077397-002 | 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 | A077397-003 | 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 | A077397-001 | 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 | A077397-002 | 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 | A077397-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077397-001 | 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 | A077397-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077397-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077397-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077397-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077397-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077397-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077397-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077397-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077397-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077397-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077397-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077397-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077397-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077397-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077397-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077397-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077397-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077397-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077397-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077397-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077397-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077397-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077397-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077397-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077397-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077397-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077397-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077397-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077397-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077397-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077397-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077397-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077397-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077397-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077397-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077397-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077397-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077397-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077397-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077397-001 | 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 | Coupler LLC | 56442b06-c135-a035-e063-6394a90a171b | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 077397 ANDA077397 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Legacy Pharmaceutical Packaging, LLC | bd86b293-dab9-4d37-95eb-2bffca335d16 | 2026-03-11 | Boxed warning, Warnings, Adverse reactions | 077397 ANDA077397 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Quallent Pharmaceuticals Health LLC | 61835f25-bfe4-49ac-9dbf-3d6387866e78 | 2026-02-01 | Boxed warning, Warnings, Adverse reactions | 077397 ANDA077397 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Cipla USA Inc. | cf71d1b9-5ebb-429f-a07f-a87cd168250f | 2026-02-01 | Boxed warning, Warnings, Adverse reactions | 077397 ANDA077397 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Northwind Health Company, LLC | ab30b0a4-6696-19da-e053-2995a90a29aa | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 077397 ANDA077397 51655-345 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Cardinal Health 107, LLC | 7e5e76cf-2fda-4f9d-bcbf-f77b1f188ee6 | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 077397 ANDA077397 55154-4687 55154-4692 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 52c88667-c67e-4d42-b319-afb354713b1e | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | 077397 ANDA077397 43063-754 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | adfcc867-1b6e-4698-94b6-2b4190c4ba3d | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | 077397 ANDA077397 43063-033 |
| SERTRALINE | SERTRALINE | Aphena Pharma Solutions - Tennessee, LLC | 1548faf9-8625-f871-e063-6394a90a931f | 2025-07-21 | Boxed warning, Warnings, Adverse reactions | 077397 ANDA077397 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | REMEDYREPACK INC. | 7d598f1a-6c76-458a-a155-7a6a0743a2d3 | 2025-05-27 | Boxed warning, Warnings, Adverse reactions | 077397 ANDA077397 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 30b94d67-0000-a045-e063-6394a90ade32 | 2025-03-19 | Boxed warning, Warnings, Adverse reactions | 077397 ANDA077397 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | American Health Packaging | 4e09f580-d612-416c-a4a4-79a4411845b2 | 2024-11-19 | Boxed warning, Warnings, Adverse reactions | 077397 ANDA077397 60687-231 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 7cadc747-5606-8efe-e053-2991aa0a1d8f | 2024-06-12 | Boxed warning, Warnings, Adverse reactions | 077397 ANDA077397 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | 22c4b114-5f70-4c64-aa7f-b4169729b847 | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | 077397 ANDA077397 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | 9bcef7ef-4e2f-4ab9-9c0f-f4956bfdd71b | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | 077397 ANDA077397 |
| SERTRALINE | SERTRALINE | Aphena Pharma Solutions - Tennessee, LLC | 7be6a62e-0e85-47c8-8793-b41c51c2557f | 2024-03-11 | Boxed warning, Warnings, Adverse reactions | 077397 ANDA077397 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Proficient Rx LP | 787a683a-091c-4908-a643-ecbc8fd467eb | 2020-02-01 | Boxed warning, Warnings, Adverse reactions | 077397 ANDA077397 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Proficient Rx LP | 00179766-980b-44b0-99d3-1fee2bb27e37 | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | 077397 ANDA077397 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Proficient Rx LP | 551d5946-00df-4608-96a2-b29f0ef93ba0 | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | 077397 ANDA077397 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-6558 | Sertraline | Sertraline Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-6559 | Sertraline | Sertraline Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-6560 | Sertraline | Sertraline Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 21695-164 | Sertraline Hydrochloride | sertraline hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 21695-165 | Sertraline Hydrochloride | sertraline hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 21695-166 | Sertraline Hydrochloride | sertraline hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 31722-212 | Sertraline Hydrochloride | Sertraline Hydrochloride | Camber Pharmaceuticals Inc. | ANDA | Current |
| 31722-213 | Sertraline Hydrochloride | Sertraline Hydrochloride | Camber Pharmaceuticals Inc. | ANDA | Current |
| 31722-214 | Sertraline Hydrochloride | Sertraline Hydrochloride | Camber Pharmaceuticals Inc. | ANDA | Current |
| 33261-170 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-171 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 35356-669 | Sertraline Hydrochloride | Sertraline Hydrochloride | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | ANDA | Current |
| 43063-033 | Sertraline Hydrochloride | Sertraline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-033 | Sertraline Hydrochloride | Sertraline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-033 | Sertraline Hydrochloride | Sertraline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-033 | Sertraline Hydrochloride | Sertraline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-033 | Sertraline Hydrochloride | Sertraline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-033 | Sertraline Hydrochloride | Sertraline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-754 | Sertraline Hydrochloride | Sertraline Hydrochloride | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-754 | Sertraline Hydrochloride | Sertraline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-754 | Sertraline Hydrochloride | Sertraline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-754 | Sertraline Hydrochloride | Sertraline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-754 | Sertraline Hydrochloride | Sertraline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-754 | Sertraline Hydrochloride | Sertraline Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43353-809 | SERTRALINE | Sertraline | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-809 | SERTRALINE | Sertraline | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-812 | SERTRALINE | Sertraline | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-817 | SERTRALINE | Sertraline | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-817 | SERTRALINE | Sertraline | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-970 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 45865-370 | Sertraline Hydrochloride | Sertraline Hydrochloride | Medsource Pharmaceuticals | ANDA | Current |
| 45865-518 | Sertraline Hydrochloride | Sertraline Hydrochloride | Medsource Pharmaceuticals | ANDA | Current |
| 45865-518 | Sertraline Hydrochloride | Sertraline Hydrochloride | Medsource Pharmaceuticals | ANDA | Current |
| 50090-2609 | Sertraline Hydrochloride | Sertraline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2609 | Sertraline Hydrochloride | Sertraline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2779 | Sertraline Hydrochloride | Sertraline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2976 | Sertraline Hydrochloride | Sertraline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3153 | Sertraline Hydrochloride | Sertraline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3217 | Sertraline Hydrochloride | Sertraline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3562 | SERTRALINE | Sertraline | A-S Medication Solutions | ANDA | Current |
| 50090-3562 | SERTRALINE | Sertraline | A-S Medication Solutions | ANDA | Current |
| 50090-3562 | SERTRALINE | Sertraline | A-S Medication Solutions | ANDA | Current |
| 50436-0834 | Sertraline Hydrochloride | Sertraline Hydrochloride | Unit Dose Services | ANDA | Current |
| 50436-0835 | Sertraline Hydrochloride | Sertraline Hydrochloride | Unit Dose Services | ANDA | Current |
| 50436-6304 | SERTRALINE | Sertraline Hydrochloride | Unit Dose Services | ANDA | Current |
| 50436-6305 | Sertraline Hydrochloride | Sertraline Hydrochloride | Unit Dose Services | ANDA | Current |
| 50436-6306 | Sertraline Hydrochloride | Sertraline Hydrochloride | Unit Dose Services | ANDA | Current |
| 51138-585 | Sertraline Hydrochloride | sertraline hydrochloride | Med-Health Pharma, LLC | ANDA | Current |
| 51655-345 | Sertraline Hydrochloride | Sertraline Hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 51655-345 | Sertraline Hydrochloride | Sertraline Hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 51655-830 | Sertraline | Sertraline | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 52959-872 | Sertraline Hydrochloride | Sertraline Hydrochloride | H.J. Harkins Company Inc. | ANDA | Current |
| 52959-875 | Sertraline Hydrochloride | Sertraline Hydrochloride | H.J. Harkins Company Inc. | ANDA | Current |
| 52959-876 | Sertraline Hydrochloride | Sertraline Hydrochloride | H.J. Harkins Company Inc. | ANDA | Current |
| 53002-1192 | Sertraline Hydrochloride | Sertraline Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1192 | Sertraline Hydrochloride | Sertraline Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1215 | Sertraline Hydrochloride | Sertraline Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1215 | Sertraline Hydrochloride | Sertraline Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1507 | Sertraline Hydrochloride | Sertraline Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1507 | Sertraline Hydrochloride | Sertraline Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53217-242 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53217-257 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53808-0579 | Sertraline Hydrochloride | sertraline hydrochloride | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0581 | Sertraline Hydrochloride | sertraline hydrochloride | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0587 | Sertraline Hydrochloride | sertraline hydrochloride | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-4687 | Sertraline Hydrochloride | Sertraline Hydrochloride | Cardinal Health 107, LLC | ANDA | Current |
| 55154-4687 | Sertraline Hydrochloride | Sertraline Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-4687 | Sertraline Hydrochloride | Sertraline Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-4687 | Sertraline Hydrochloride | Sertraline Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-4692 | Sertraline Hydrochloride | Sertraline Hydrochloride | Cardinal Health 107, LLC | ANDA | Current |
| 55154-4692 | Sertraline Hydrochloride | Sertraline Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-4692 | Sertraline Hydrochloride | Sertraline Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-4692 | Sertraline Hydrochloride | Sertraline Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-6627 | Sertraline | Sertraline Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-6627 | Sertraline | Sertraline Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-6631 | Sertraline | Sertraline Hydrochloride | Cardinal Health | ANDA | Current |
| 58118-0834 | Sertraline Hydrochloride | Sertraline Hydrochloride | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-0834 | Sertraline Hydrochloride | Sertraline Hydrochloride | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-0834 | Sertraline Hydrochloride | Sertraline Hydrochloride | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 60687-231 | Sertraline Hydrochloride | Sertraline Hydrochloride | American Health Packaging | ANDA | Current |