Application 205983
- Type
- ANDA
- Sponsor
- IPCA LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 25MG BASE | No | No |
| 002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 50MG BASE | No | No |
| 003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 100MG BASE | No | No |
| 004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 200MG BASE | No | No |
| 005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 300MG BASE | No | No |
| 006 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 400MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205983-001 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | 2024-05-20 | ||
| A205983-002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | 2024-05-20 | ||
| A205983-003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | 2024-05-20 | ||
| A205983-004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | 2024-05-20 | ||
| A205983-005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | 2024-05-20 | ||
| A205983-006 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | 2024-05-20 |
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 | A205983-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | 2024-05-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A205983-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | 2024-05-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A205983-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | 2024-05-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A205983-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | 2024-05-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A205983-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | 2024-05-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A205983-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | 2024-05-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205983-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | 2024-05-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205983-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | 2024-05-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205983-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | 2024-05-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205983-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | 2024-05-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205983-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | 2024-05-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205983-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | 2024-05-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205983-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | 2024-05-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205983-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | 2024-05-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205983-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | 2024-05-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205983-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | 2024-05-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205983-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | 2024-05-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205983-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | 2024-05-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205983-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | 2024-05-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205983-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | 2024-05-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205983-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | 2024-05-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205983-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | 2024-05-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205983-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | 2024-05-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205983-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | 2024-05-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205983-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | 2024-05-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205983-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | 2024-05-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205983-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | 2024-05-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205983-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | 2024-05-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205983-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | 2024-05-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205983-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | 2024-05-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205983-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | 2024-05-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205983-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | 2024-05-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205983-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | 2024-05-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205983-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | 2024-05-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205983-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | 2024-05-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205983-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | 2024-05-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205983-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | 2024-05-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205983-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | 2024-05-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205983-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | 2024-05-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205983-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | 2024-05-20 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205983-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205983-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205983-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205983-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205983-005 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205983-006 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205983-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205983-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205983-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205983-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205983-005 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205983-006 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205983-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205983-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205983-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205983-004 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205983-005 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205983-006 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A205983-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205983-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205983-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205983-004 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205983-005 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205983-006 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205983-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205983-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205983-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205983-004 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205983-005 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205983-006 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205983-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205983-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205983-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205983-004 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205983-005 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205983-006 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205983-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205983-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205983-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205983-004 | AB | 1 | 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 |
|---|---|---|---|---|---|---|
| Quetiapine fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 35f6ad40-192a-4d1f-ace0-9fb69b9d984d | 2025-02-03 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 385f7c3d-3299-4b04-947e-de2ee78c8241 | 2025-01-31 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Direct Rx | db48ec02-1119-f343-e053-2a95a90afb3b | 2025-01-22 | Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Direct_Rx | face6c19-3dd9-b188-e053-6294a90a62d0 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Direct_Rx | fceb9f47-8da7-7138-e053-6294a90a5558 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Preferred Pharmaceuticals Inc. | 8acc0ed3-6e4f-4799-8252-5a163938fddc | 2025-01-16 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Advanced Rx Pharmacy of Tennessee, LLC | d323b6c0-55fa-6caa-e053-2a95a90a3cff | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Advanced Rx Pharmacy of Tennessee, LLC | d2a76aed-a0b8-33f0-e053-2a95a90add0f | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | A-S Medication Solutions | 132a2483-7e49-4b0c-9db4-e6e578697fd9 | 2024-12-20 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | d779f317-683b-4ec6-a309-1dd54332563f | 2024-08-29 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Advanced Rx of Tennessee, LLC | 1cfc847b-0d8d-fc94-e063-6394a90a311f | 2024-07-11 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 293a9857-d138-4583-abc9-35b75660e324 | 2024-05-20 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Camber Pharmaceuticals, Inc. | 5c6aeb85-3ac2-4448-b544-9a4c5f562ed3 | 2024-04-18 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | A-S Medication Solutions | 845159aa-1ac2-41b7-ac21-d4b03e43203b | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Proficient Rx LP | 392dd5cf-4777-4985-b62b-7370134dee26 | 2024-04-01 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | NuCare Pharmaceuticals,Inc. | 0fdbe32f-d04a-5666-e063-6294a90a8e36 | 2024-01-26 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | A-S Medication Solutions | ccacb909-8ee5-4223-bfee-9cfeae470ecf | 2023-11-24 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Proficient Rx LP | 2b387188-c2c1-4865-984c-341a358d1c6c | 2023-10-01 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Proficient Rx LP | 85f973e0-93e6-4856-9266-62136acb2532 | 2023-08-01 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | A-S Medication Solutions | 95156201-ed16-4806-98a7-d42acc902126 | 2023-06-15 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.