Application 077977
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
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 |
| 004 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 150MG BASE | No | No |
| 005 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 200MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077977-001 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2007-02-06 | ||
| A077977-002 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2007-02-06 | ||
| A077977-003 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2007-02-06 | ||
| A077977-004 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2007-02-06 | ||
| A077977-005 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | TABLET / ORAL | 2007-02-06 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077977-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2007-02-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077977-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2007-02-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077977-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2007-02-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077977-004 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2007-02-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077977-005 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | TABLET / ORAL | 2007-02-06 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077977-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2007-02-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077977-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2007-02-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077977-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2007-02-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077977-004 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2007-02-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077977-005 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | TABLET / ORAL | 2007-02-06 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077977-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2007-02-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077977-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2007-02-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077977-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2007-02-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077977-004 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2007-02-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077977-005 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | TABLET / ORAL | 2007-02-06 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077977-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2007-02-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077977-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2007-02-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077977-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2007-02-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077977-004 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2007-02-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077977-005 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | TABLET / ORAL | 2007-02-06 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077977-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2007-02-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077977-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2007-02-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077977-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2007-02-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077977-004 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2007-02-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077977-005 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | TABLET / ORAL | 2007-02-06 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077977-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2007-02-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077977-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2007-02-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077977-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2007-02-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077977-004 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2007-02-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077977-005 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | TABLET / ORAL | 2007-02-06 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077977-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2007-02-06 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077977-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2007-02-06 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077977-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2007-02-06 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077977-004 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2007-02-06 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077977-005 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | TABLET / ORAL | 2007-02-06 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077977-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2007-02-06 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077977-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2007-02-06 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077977-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2007-02-06 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077977-004 | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2007-02-06 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077977-005 | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE | TABLET / ORAL | 2007-02-06 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A077977-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077977-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077977-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A077977-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077977-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077977-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077977-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077977-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077977-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077977-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077977-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077977-003 | AB | 1 | ea99ee380514… |
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 | REMEDYREPACK INC. | 7d598f1a-6c76-458a-a155-7a6a0743a2d3 | 2026-09-03 | Boxed warning, Warnings, Adverse reactions | Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE |
| Sertraline hydrochloride | SERTRALINE HYDROCHLORIDE | REMEDYREPACK INC. | 455c8416-c878-4283-a42f-4df896870a4e | 2026-08-28 | Boxed warning, Warnings, Adverse reactions | Sertraline hydrochloride SERTRALINE HYDROCHLORIDE |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | b559c20d-70be-41e7-acfb-262ffc3ea878 | 2026-08-28 | Boxed warning, Warnings, Adverse reactions | Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 5921f77f-01a2-40b9-ad77-2258865c997d | 2026-08-28 | Boxed warning, Warnings, Adverse reactions | Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE |
| Sertraline hydrochloride | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 4da914d0-629e-4766-b57f-6119fa8283cf | 2026-08-28 | Boxed warning, Warnings, Adverse reactions | Sertraline hydrochloride SERTRALINE HYDROCHLORIDE |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 677c90cd-6527-40cb-a564-571796513fcb | 2026-08-28 | Boxed warning, Warnings, Adverse reactions | Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE |
| Sertraline hydrochloride | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 1afd0016-d0ee-4e25-a1a4-b66f228e2f9c | 2026-08-27 | Boxed warning, Warnings, Adverse reactions | Sertraline hydrochloride SERTRALINE HYDROCHLORIDE |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Cardinal Health 107, LLC | 7e5e76cf-2fda-4f9d-bcbf-f77b1f188ee6 | 2026-08-25 | Boxed warning, Warnings, Adverse reactions | Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE |
| Sertraline HCl | SERTRALINE HYDROCHLORIDE | Umedica Laboratories USA Inc. | a6d0f35c-f4f4-456d-b8d9-d56297261ad6 | 2026-08-17 | Boxed warning, Warnings, Adverse reactions | SERTRALINE HYDROCHLORIDE |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | adfcc867-1b6e-4698-94b6-2b4190c4ba3d | 2026-08-07 | Boxed warning, Warnings, Adverse reactions | Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 52c88667-c67e-4d42-b319-afb354713b1e | 2026-08-07 | Boxed warning, Warnings, Adverse reactions | Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Proficient Rx LP | 9dacf5b7-1a23-4767-a074-11f26623e48b | 2026-08-01 | Boxed warning, Warnings, Adverse reactions | Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | REMEDYREPACK INC. | 91e24d17-ff0a-449c-9472-b9df74c98456 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | REMEDYREPACK INC. | a2f333af-d37b-4705-ab7a-d363e3186e6e | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE |
| Sertraline hydrochloride | SERTRALINE HYDROCHLORIDE | REMEDYREPACK INC. | 9d49e2cb-a852-403d-b92b-e7d3fa88032c | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | Sertraline hydrochloride SERTRALINE HYDROCHLORIDE |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | f6346a11-88b9-4425-b08d-a22f19c4ceb4 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE |
| SERTRALINE | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 7b5c29ff-25c8-4b68-844d-b8e95be7d09b | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | SERTRALINE HYDROCHLORIDE |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Coupler LLC | 56442b06-c135-a035-e063-6394a90a171b | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 561a8a20-be26-c4f8-e063-6394a90af072 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 561e7498-a606-366d-e063-6394a90a1c6a | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE |
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 |
|---|---|---|---|---|---|
| 63304-164 | Sertraline Hydrochloride | Sertraline Hydrochloride | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-165 | Sertraline Hydrochloride | Sertraline Hydrochloride | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-166 | Sertraline Hydrochloride | Sertraline Hydrochloride | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-167 | Sertraline Hydrochloride | Sertraline Hydrochloride | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-168 | Sertraline Hydrochloride | Sertraline Hydrochloride | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |