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 | Proficient Rx LP | c1f2ccba-62f3-44e7-b06f-dea61eac9e93 | 2023-04-01 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Macleods Pharmaceuticals Limited | 531cbe20-dff2-4983-9788-4543079f83ff | 2023-03-16 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Alembic Pharmaceuticals Limited | 93ab6237-321e-4a2c-b0ca-3fc9acb31f9a | 2023-01-30 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Proficient Rx LP | 1a147d6c-8af8-4379-8a13-1864a9a79b84 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Proficient Rx LP | 8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60 | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Aphena Pharma Solutions - Tennessee, LLC | 60316ccd-c042-4ea0-9d05-3caf7cc2cab1 | 2021-10-15 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Proficient Rx LP | 03517f29-f270-4350-a57a-fbe1967b0096 | 2019-10-01 | 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.