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 | BluePoint Laboratories | 874e50ad-5da0-4ac3-9290-79442c91399e | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | Bryant Ranch Prepack | a45d8b77-f13d-41c5-8d50-15152fc6f85c | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | QUETIAPINE FUMARATE QUETIAPINE FUMARATE |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 4e1e5249-1cb7-4cc2-ad5a-cdeeee2f494f | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | QUETIAPINE FUMARATE QUETIAPINE FUMARATE |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 45c4c3a4-3acc-413e-9746-4816d513fac6 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | QUETIAPINE FUMARATE QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | XLCare Pharmaceuticals Inc. | 070faf07-0ce7-4354-8643-9d222b72ecad | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | A-S Medication Solutions | 55018271-1f8f-4683-afee-8203c3bd9acc | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Direct_Rx | f6de1d2b-b10e-2e9a-e053-6394a90a735d | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | A-S Medication Solutions | 42bd7dd3-9f81-4d8b-bce9-302e5559da2f | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | 479c9555-5d1e-4e5c-bfde-f3812829edd8 | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Preferred Pharmaceuticals, Inc. | 1fe839fa-c566-4374-997f-f5b9d97b5fb8 | 2026-01-21 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | : Preferred Pharmaceuticals Inc. | f3c91d05-038b-40f4-8c1f-2910773ec567 | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Coupler LLC | 4872793c-a7be-1b65-e063-6394a90a8b3a | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | A-S Medication Solutions | aeff3ab1-24ff-417a-8bbc-2ffa413dcb87 | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | NuCare Pharmaceuticals,Inc. | 471d8e2d-4be6-6180-e063-6394a90ac721 | 2025-12-29 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE | A-S Medication Solutions | 10288afa-c4dc-4897-9ec8-f4573d850779 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | AvPAK | 6b7d7d2f-a50b-8e21-2de4-ccc102016384 | 2025-12-16 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | NuCare Pharmaceuticals, Inc. | 458cae68-c11d-e760-e063-6394a90ac04e | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Ingenus Pharmaceuticals, LLC | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | Accord Healthcare Inc. | 72111c36-c625-434f-9f16-7f25e0ff75f3 | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | QUETIAPINE FUMARATE QUETIAPINE FUMARATE |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | Accord Healthcare Inc. | 3ffe0294-3959-2755-e054-00144ff8d46c | 2025-11-14 | 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.