Application 077206
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA
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 |
|---|---|---|---|---|---|---|---|
| A077206-001 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | |
| A077206-002 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | |
| A077206-003 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077206-001 | AB |
| A077206-002 | AB |
| A077206-003 | 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 | A077206-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077206-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077206-003 | 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 | A077206-001 | 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 | A077206-002 | 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 | A077206-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077206-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077206-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077206-003 | 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 | A077206-001 | 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 | A077206-002 | 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 | A077206-003 | 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 | A077206-001 | 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 | A077206-002 | 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 | A077206-003 | 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 | A077206-001 | 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 | A077206-002 | 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 | A077206-003 | 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 | A077206-001 | 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 | A077206-002 | 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 | A077206-003 | 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 | A077206-001 | 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 | A077206-002 | 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 | A077206-003 | 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 | A077206-001 | 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 | A077206-002 | 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 | A077206-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077206-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077206-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077206-003 | 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 | A077206-001 | 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 | A077206-002 | 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 | A077206-003 | 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 | A077206-001 | 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 | A077206-002 | 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 | A077206-003 | 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 | A077206-001 | 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 | A077206-002 | 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 | A077206-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077206-001 | 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 | A077206-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077206-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077206-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077206-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077206-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077206-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077206-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077206-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077206-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077206-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077206-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077206-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077206-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077206-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077206-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077206-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077206-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077206-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077206-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077206-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077206-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077206-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077206-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077206-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077206-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077206-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077206-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077206-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077206-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077206-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077206-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077206-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077206-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077206-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077206-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077206-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077206-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077206-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077206-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077206-001 | 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 | Bryant Ranch Prepack | 5c6c817e-a555-4f55-837d-94458787fcb6 | 2024-05-22 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline HCL | SERTRALINE HCL | Direct_Rx | 1766ea8b-bb88-8bb8-e063-6394a90a032d | 2024-05-16 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Aurobindo Pharma Limited | 39a85db1-9e59-4ab0-9e18-36757f019faa | 2024-02-09 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 65862-011 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | NorthStar Rx LLC | 9bc362d4-489c-4e7f-915a-3076ff8d132a | 2024-02-09 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 16714-611 16714-613 16714-612 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 75a43476-25e0-44c3-bbab-2160041032d1 | 2023-12-25 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 626a9271-a268-4194-935d-779377f902f5 | 2023-12-05 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 286b429d-62b9-4ca8-a243-de3f619315bf | 2023-09-10 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 50090-2080 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 513ecb5b-062f-455f-b798-1c9a54222ff3 | 2023-02-28 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Proficient Rx LP | 0f264823-1cba-4478-aef1-a8587f221dbb | 2022-12-01 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Proficient Rx LP | ba201164-f6f7-4779-87a3-62780f332113 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Proficient Rx LP | a0b4b9c9-bd5b-4900-8abf-b55d3283c53c | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | e815c67d-951c-4cb3-a840-f0b493b97da1 | 2020-06-23 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 13107-011 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurolife Pharma LLC | ANDA | Current |
| 13107-012 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurolife Pharma LLC | ANDA | Current |
| 13107-013 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurolife Pharma LLC | ANDA | Current |
| 16714-611 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-611 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-611 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-611 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-611 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-611 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-611 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-612 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-612 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-612 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-612 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-612 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-612 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-612 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-613 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-613 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-613 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-613 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-613 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-613 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-613 | Sertraline Hydrochloride | Sertraline Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 42708-050 | Sertraline Hydrochloride | Sertraline Hydrochloride | QPharma Inc | ANDA | Current |
| 42708-124 | Sertraline Hydrochloride | Sertraline Hydrochloride | QPharma Inc | ANDA | Current |
| 42708-124 | Sertraline Hydrochloride | Sertraline Hydrochloride | QPharma Inc | ANDA | Current |
| 42708-124 | Sertraline Hydrochloride | Sertraline Hydrochloride | QPharma Inc | ANDA | Current |
| 43353-447 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-1847 | Sertraline Hydrochloride | Sertraline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1847 | Sertraline Hydrochloride | Sertraline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2080 | Sertraline Hydrochloride | Sertraline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2080 | Sertraline Hydrochloride | Sertraline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3112 | Sertraline Hydrochloride | Sertraline Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50436-0011 | Sertraline Hydrochloride | Sertraline Hydrochloride | Unit Dose Services | ANDA | Current |
| 50436-0012 | Sertraline Hydrochloride | Sertraline Hydrochloride | Unit Dose Services | ANDA | Current |
| 50436-0013 | Sertraline Hydrochloride | Sertraline Hydrochloride | Unit Dose Services | ANDA | Current |
| 50436-0611 | Sertraline Hydrochloride | Sertraline Hydrochloride | Unit Dose Services | ANDA | Current |
| 51655-173 | Sertraline Hydrochloride | Sertraline Hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 51655-173 | Sertraline Hydrochloride | Sertraline Hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 51655-265 | Sertraline Hydrochloride | Sertraline Hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 51655-265 | Sertraline Hydrochloride | Sertraline Hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 53002-2507 | Sertraline Hydrochloride | Sertraline Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-3192 | Sertraline Hydrochloride | Sertraline Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-3192 | Sertraline Hydrochloride | Sertraline Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-3215 | Sertraline Hydrochloride | Sertraline Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53808-1127 | Sertraline Hydrochloride | Sertraline Hydrochloride | DOH CENTRAL PHARMACY | ANDA | Current |
| 55700-340 | Sertraline Hydrochloride | Sertraline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-340 | Sertraline Hydrochloride | Sertraline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-340 | Sertraline Hydrochloride | Sertraline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-340 | Sertraline Hydrochloride | Sertraline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-340 | Sertraline Hydrochloride | Sertraline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-362 | Sertraline Hydrochloride | Sertraline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-362 | Sertraline Hydrochloride | Sertraline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-362 | Sertraline Hydrochloride | Sertraline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-362 | Sertraline Hydrochloride | Sertraline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-362 | Sertraline Hydrochloride | Sertraline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-562 | Sertraline Hydrochloride | Sertraline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-562 | Sertraline Hydrochloride | Sertraline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-562 | Sertraline Hydrochloride | Sertraline Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60760-091 | Sertraline Hydrochloride | Sertraline Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-091 | Sertraline Hydrochloride | Sertraline Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-611 | Sertraline Hydrochloride | Sertraline Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-612 | Sertraline Hydrochloride | Sertraline Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-014 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-014 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 63629-6370 | Sertraline Hydrochloride | Sertraline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-6370 | Sertraline Hydrochloride | Sertraline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8125 | Sertraline Hydrochloride | Sertraline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8125 | Sertraline Hydrochloride | Sertraline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8127 | Sertraline Hydrochloride | Sertraline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8127 | Sertraline Hydrochloride | Sertraline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8128 | Sertraline Hydrochloride | Sertraline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8128 | Sertraline Hydrochloride | Sertraline Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63739-490 | Sertraline Hydrochloride | Sertraline Hydrochloride | McKesson Packaging Services Business Unit of McKesson Corporation | ANDA | Current |
| 65862-011 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-011 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-011 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-011 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-011 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31206 | ORIG | 2005-09-22 |