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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 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… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 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… |
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 | Preferred Pharmaceuticals Inc. | b559c20d-70be-41e7-acfb-262ffc3ea878 | 2026-08-28 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 68788-6437 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 5921f77f-01a2-40b9-ad77-2258865c997d | 2026-08-28 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 68788-6429 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 677c90cd-6527-40cb-a564-571796513fcb | 2026-08-28 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 68788-6835 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | REMEDYREPACK INC. | 91e24d17-ff0a-449c-9472-b9df74c98456 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 70518-2812 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | REMEDYREPACK INC. | a2f333af-d37b-4705-ab7a-d363e3186e6e | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 70518-2448 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 561a8a20-be26-c4f8-e063-6394a90af072 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 561e7498-a606-366d-e063-6394a90a1c6a | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | REMEDYREPACK INC. | 575da603-b038-421f-9894-6796d9ac33cc | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 70518-1748 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 8d444aec-cf33-b769-e053-2995a90a54be | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Coupler LLC | 518caa95-2cd7-a293-e063-6394a90adbd0 | 2026-05-11 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 7f81de84-0ad7-f050-e053-2a91aa0aa762 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Coupler LLC | 5103d12c-9453-a855-e063-6294a90a6f0c | 2026-05-04 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 7f62789b-61df-4b7b-9e01-c7a4dfb7e73c | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 90524e6e-c34f-43eb-8c30-d99faf7ae08f | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Northwind Health Company, LLC | ab0b0ef7-155b-cec9-e053-2a95a90a9fce | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Northwind Health Company, LLC | ab1bb71f-936d-cb40-e053-2a95a90a08bb | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | QPharma Inc | 664d1744-7b1d-43e2-98ba-1b0e69d75840 | 2025-12-03 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Aurobindo Pharma Limited | b497dfeb-a48c-4f2a-b309-b56f3a26a19b | 2025-11-24 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Bryant Ranch Prepack | b400fed8-f425-47ff-ab42-915cb6e7f152 | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
| Sertraline Hydrochloride | SERTRALINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 8f5a71b2-2821-46a0-ac65-28d9b2db73ec | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | 077206 ANDA077206 |
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 |