Application 078626
- Type
- ANDA
- Sponsor
- MYLAN PHARMS INC
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 |
|---|---|---|---|---|---|---|---|
| A078626-001 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | ||
| A078626-002 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | ||
| A078626-003 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 |
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 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078626-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | 2008-01-31 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078626-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2008-01-31 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078626-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | 2008-01-31 | 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 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 | 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 | REMEDYREPACK INC. | e554537c-9469-4f9a-9157-d5763bb8b720 | 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 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 55f514c6-f6ec-13ac-e063-6294a90ac957 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE |
| Sertraline hydrochloride | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | 9c0a7f78-9cac-4e82-b971-f3f9758f8a0c | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | Sertraline hydrochloride SERTRALINE HYDROCHLORIDE |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | REMEDYREPACK INC. | 575da603-b038-421f-9894-6796d9ac33cc | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE |
| Sertraline hydrochloride | SERTRALINE HYDROCHLORIDE | Northwind Health Company, LLC | 4ddfd698-3d47-fc0e-e063-6394a90accec | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | Sertraline hydrochloride SERTRALINE HYDROCHLORIDE |
| Sertraline hydrochloride | SERTRALINE HYDROCHLORIDE | Coupler LLC | 544d1ed1-da06-976d-e063-6394a90afe79 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | Sertraline hydrochloride SERTRALINE HYDROCHLORIDE |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | e919f195-0ce1-4d71-9883-efec05b9a050 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 8d444aec-cf33-b769-e053-2995a90a54be | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 730448bf-2d78-44a4-e053-2991aa0ada9e | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-8011 | Sertraline Hydrochloride | sertraline | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-8121 | Sertraline Hydrochloride | sertraline | Mylan Pharmaceuticals Inc | ANDA | Current |
| 43353-787 | Sertraline Hydrochloride | sertraline | Aphena Pharma Solutions - Tennessee, Inc. | ANDA | Current |
| 53808-0954 | Sertraline Hydrochloride | sertraline | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-1060 | Sertraline Hydrochloride | sertraline | State of Florida DOH Central Pharmacy | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44390 | ORIG | 2008-02-28 |