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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A077206-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A077206-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A077206-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A077206-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077206-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077206-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A077206-001 | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET / ORAL | AB | 2007-02-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077206-002 | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2007-02-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077206-003 | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | 2007-02-06 | caaa826d4ba7… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A077206-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A077206-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A077206-003 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A077206-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077206-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077206-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A077206-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077206-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077206-003 | AB | 1 | caaa826d4ba7… |
| 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… |
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 | PD-Rx Pharmaceuticals, Inc. | 3ca30f3f-545e-46c5-b56a-73ec48e9647f | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 91b4c802-9c6b-49bb-b5a7-661e1917ef34 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | 50d0aef5-ecc7-49b0-964a-53f87058d22a | 2025-07-30 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 680890b1-bc45-4f50-9aaf-e730ab515b85 | 2025-03-06 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Asclemed USA, Inc. | e25a13c3-a173-4cc3-99d3-0be43abbc498 | 2025-02-12 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | DIRECT RX | ab962a5a-fff6-2cf9-e053-2995a90ace0f | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | c4bad433-623b-402c-b454-d39f19a23627 | 2025-01-14 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 0e5a7b02-3972-47f0-9f49-e958d792beac | 2025-01-14 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | ae3be25b-2bde-4142-ad56-920a96ac8f39 | 2025-01-13 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | ec1b68d3-ff55-d0a2-e053-2a95a90a2e0b | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f8c45a99-18ed-0e1f-e053-6394a90a2d52 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Quality Care Products LLC | 25aef6c1-9964-44a1-a905-c37e5c28a3c0 | 2024-12-17 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | 9f1d5689-3bf1-431c-9ea2-9e37217ecf40 | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | 4191b929-5bdb-4388-9e4d-fffce55bc363 | 2024-10-18 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | c6897cf2-1349-400d-ab22-1e88f097b693 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | 2f81b0c4-9ad9-4dda-8950-70321a8769e4 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 8e105aeb-6e17-a025-e053-2995a90aba77 | 2024-06-18 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 68071-4973 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 8e98ee4c-24df-88ce-e053-2a95a90a6713 | 2024-06-18 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 68071-4993 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 6dd71a5b-1923-54fb-e053-2991aa0a619e | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 68071-4462 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 71224928-685a-355c-e053-2995a90a0a5b | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 68071-4494 |
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 |
|---|---|---|---|---|---|
| 65862-011 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-012 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-012 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-012 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-012 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-012 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-012 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-013 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-013 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-013 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-013 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-013 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-013 | Sertraline Hydrochloride | Sertraline Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 66116-371 | Sertraline Hydrochloride | Sertraline Hydrochloride | MedVantx, Inc. | ANDA | Current |
| 66116-376 | Sertraline Hydrochloride | Sertraline Hydrochloride | MedVantx, Inc. | ANDA | Current |
| 66116-377 | Sertraline Hydrochloride | Sertraline Hydrochloride | MedVantx, Inc. | ANDA | Current |
| 67046-554 | Sertraline Hydrochloride | Sertraline Hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-555 | Sertraline Hydrochloride | Sertraline Hydrochloride | Contract Pharmacy Services- PA | ANDA | Current |
| 67046-559 | Sertraline Hydrochloride | Sertraline Hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 68071-1911 | Sertraline Hydrochloride | Sertraline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1911 | Sertraline Hydrochloride | Sertraline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2162 | Sertraline Hydrochloride | Sertraline Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-2767 | Sertraline Hydrochloride | Sertraline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4370 | Sertraline Hydrochloride | Sertraline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4370 | Sertraline Hydrochloride | Sertraline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4370 | Sertraline Hydrochloride | Sertraline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4370 | Sertraline Hydrochloride | Sertraline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4462 | Sertraline Hydrochloride | Sertraline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4462 | Sertraline Hydrochloride | Sertraline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4462 | Sertraline Hydrochloride | Sertraline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4494 | Sertraline Hydrochloride | Sertraline Hydrochloride | NuCare Pharmaceuticals,In | ANDA | Current |
| 68071-4494 | Sertraline Hydrochloride | Sertraline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4494 | Sertraline Hydrochloride | Sertraline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4494 | Sertraline Hydrochloride | Sertraline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4973 | Sertraline Hydrochloride | Sertraline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4973 | Sertraline Hydrochloride | Sertraline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4993 | Sertraline Hydrochloride | Sertraline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4993 | Sertraline Hydrochloride | Sertraline Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-6429 | Sertraline Hydrochloride | Sertraline Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6429 | Sertraline Hydrochloride | Sertraline Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6429 | Sertraline Hydrochloride | Sertraline Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6429 | Sertraline Hydrochloride | Sertraline Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6429 | Sertraline Hydrochloride | Sertraline Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6437 | Sertraline Hydrochloride | Sertraline Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6437 | Sertraline Hydrochloride | Sertraline Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6437 | Sertraline Hydrochloride | Sertraline Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6437 | Sertraline Hydrochloride | Sertraline Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6437 | Sertraline Hydrochloride | Sertraline Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6835 | Sertraline Hydrochloride | Sertraline Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6835 | Sertraline Hydrochloride | Sertraline Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6835 | Sertraline Hydrochloride | Sertraline Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6835 | Sertraline Hydrochloride | Sertraline Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6835 | Sertraline Hydrochloride | Sertraline Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0679 | Sertraline Hydrochloride | Sertraline Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0679 | Sertraline Hydrochloride | Sertraline Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1748 | Sertraline Hydrochloride | Sertraline Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1748 | Sertraline Hydrochloride | Sertraline Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1748 | Sertraline Hydrochloride | Sertraline Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1748 | Sertraline Hydrochloride | Sertraline Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1748 | Sertraline Hydrochloride | Sertraline Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1748 | Sertraline Hydrochloride | Sertraline Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2448 | Sertraline Hydrochloride | Sertraline Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2448 | Sertraline Hydrochloride | Sertraline Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2448 | Sertraline Hydrochloride | Sertraline Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2448 | Sertraline Hydrochloride | Sertraline Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2448 | Sertraline Hydrochloride | Sertraline Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2812 | Sertraline Hydrochloride | Sertraline Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2812 | Sertraline Hydrochloride | Sertraline Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2812 | Sertraline Hydrochloride | Sertraline Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2812 | Sertraline Hydrochloride | Sertraline Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70934-019 | Sertraline Hydrochloride | Sertraline Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-188 | Sertraline Hydrochloride | Sertraline Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-188 | Sertraline Hydrochloride | Sertraline Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-190 | Sertraline Hydrochloride | Sertraline Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-190 | Sertraline Hydrochloride | Sertraline Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-192 | Sertraline Hydrochloride | Sertraline Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-192 | Sertraline Hydrochloride | Sertraline Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-205 | Sertraline Hydrochloride | Sertraline Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-205 | Sertraline Hydrochloride | Sertraline Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-205 | Sertraline Hydrochloride | Sertraline Hydrochloride | Proficient Rx LP | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31206 | ORIG | 2005-09-22 |