Application 202674
- Type
- ANDA
- Sponsor
- UNICHEM 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 |
|---|---|---|---|---|---|---|---|
| A202674-001 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2016-03-08 | |
| A202674-002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2016-03-08 | |
| A202674-003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2016-03-08 | |
| A202674-004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2016-03-08 | |
| A202674-005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2016-03-08 | |
| A202674-006 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2016-03-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202674-001 | AB |
| A202674-002 | AB |
| A202674-003 | AB |
| A202674-004 | AB |
| A202674-005 | AB |
| A202674-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202674-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2016-03-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202674-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2016-03-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202674-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2016-03-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202674-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2016-03-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202674-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2016-03-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202674-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2016-03-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202674-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2016-03-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202674-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2016-03-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202674-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2016-03-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202674-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2016-03-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202674-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2016-03-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202674-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2016-03-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202674-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2016-03-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202674-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2016-03-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202674-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2016-03-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202674-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2016-03-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202674-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2016-03-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202674-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2016-03-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202674-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2016-03-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202674-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2016-03-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202674-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2016-03-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202674-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2016-03-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202674-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2016-03-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202674-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2016-03-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202674-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2016-03-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202674-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2016-03-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202674-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2016-03-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202674-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2016-03-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202674-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2016-03-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202674-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2016-03-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202674-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2016-03-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202674-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2016-03-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202674-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2016-03-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202674-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2016-03-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202674-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2016-03-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202674-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2016-03-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202674-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2016-03-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202674-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2016-03-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202674-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2016-03-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202674-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2016-03-08 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202674-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202674-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202674-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202674-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202674-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202674-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202674-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202674-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202674-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202674-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202674-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202674-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202674-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202674-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202674-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202674-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202674-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202674-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202674-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202674-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202674-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202674-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202674-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202674-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202674-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202674-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202674-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202674-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202674-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202674-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202674-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202674-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202674-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202674-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202674-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202674-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202674-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202674-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202674-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202674-004 | AB | 1 | 2680178bc6a6… |
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 | REMEDYREPACK INC. | b84e1614-b077-4ea5-8d11-df68f2b926de | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | 202674 ANDA202674 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | A-S Medication Solutions | 42bd7dd3-9f81-4d8b-bce9-302e5559da2f | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | 202674 ANDA202674 50090-3983 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | 479c9555-5d1e-4e5c-bfde-f3812829edd8 | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | 202674 ANDA202674 70518-2175 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Coupler LLC | 4872793c-a7be-1b65-e063-6394a90a8b3a | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | 202674 ANDA202674 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | NuCare Pharmaceuticals, Inc. | 458cae68-c11d-e760-e063-6394a90ac04e | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | 202674 ANDA202674 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 1618989e-2e6b-49ff-81b5-cf80d1dcfab4 | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | 202674 ANDA202674 71335-1353 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | NCS HealthCare of KY, LLC dba Vangard Labs | d73655d3-4b3f-40b4-92cb-053ad4f21a92 | 2025-02-27 | Boxed warning, Warnings, Adverse reactions | 202674 ANDA202674 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Unichem Pharmaceuticals (USA), Inc. | bdc9354b-172e-4bb3-895a-6c7cfef0ef14 | 2025-02-20 | Boxed warning, Warnings, Adverse reactions | 202674 ANDA202674 29300-152 29300-151 29300-150 29300-149 29300-148 29300-147 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Advanced Rx Pharmacy of Tennessee, LLC | d323b6c0-55fa-6caa-e053-2a95a90a3cff | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 202674 ANDA202674 80425-0184 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | A-S Medication Solutions | 845159aa-1ac2-41b7-ac21-d4b03e43203b | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 202674 ANDA202674 50090-3377 50090-3303 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 29300-147 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-147 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-147 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-147 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-147 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-147 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-148 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-148 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-148 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-148 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-148 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-148 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-149 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-149 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-149 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-149 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-149 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-149 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-150 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-150 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-150 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-150 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-150 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-150 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-151 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-151 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-151 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-151 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-151 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-151 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-152 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-152 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-152 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-152 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-152 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-152 | Quetiapine Fumarate | Quetiapine Fumarate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 50090-3303 | Quetiapine Fumarate | Quetiapine Fumarate | A-S Medication Solutions | ANDA | Current |
| 50090-3303 | Quetiapine Fumarate | Quetiapine Fumarate | A-S Medication Solutions | ANDA | Current |
| 50090-3377 | Quetiapine Fumarate | Quetiapine Fumarate | A-S Medication Solutions | ANDA | Current |
| 50090-3377 | Quetiapine Fumarate | Quetiapine Fumarate | A-S Medication Solutions | ANDA | Current |
| 50090-3377 | Quetiapine Fumarate | Quetiapine Fumarate | A-S Medication Solutions | ANDA | Current |
| 50090-3377 | Quetiapine Fumarate | Quetiapine Fumarate | A-S Medication Solutions | ANDA | Current |
| 50090-3379 | Quetiapine Fumarate | Quetiapine Fumarate | A-S Medication Solutions | ANDA | Current |
| 50090-3392 | Quetiapine Fumarate | Quetiapine Fumarate | A-S Medication Solutions | ANDA | Current |
| 50090-3540 | Quetiapine Fumarate | Quetiapine Fumarate | A-S Medication Solutions | ANDA | Current |
| 50090-3983 | Quetiapine Fumarate | Quetiapine Fumarate | A-S Medication Solutions | ANDA | Current |
| 50090-3983 | Quetiapine Fumarate | Quetiapine Fumarate | A-S Medication Solutions | ANDA | Current |
| 50090-4022 | Quetiapine Fumarate | Quetiapine Fumarate | A-S Medication Solutions | ANDA | Current |
| 50090-4022 | Quetiapine Fumarate | Quetiapine Fumarate | A-S Medication Solutions | ANDA | Current |
| 50090-4022 | Quetiapine Fumarate | Quetiapine Fumarate | A-S Medication Solutions | ANDA | Current |
| 50090-4022 | Quetiapine Fumarate | Quetiapine Fumarate | A-S Medication Solutions | ANDA | Current |
| 55700-833 | Quetiapine Fumarate | Quetiapine Fumarate | Quality Care Products, LLC | ANDA | Current |
| 68788-7538 | Quetiapine Fumarate | Quetiapine Fumarate | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7538 | Quetiapine Fumarate | Quetiapine Fumarate | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0638 | Quetiapine Fumarate | Quetiapine Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0638 | Quetiapine Fumarate | Quetiapine Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0723 | Quetiapine Fumarate | Quetiapine Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0723 | Quetiapine Fumarate | Quetiapine Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0989 | Quetiapine Fumarate | Quetiapine Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0989 | Quetiapine Fumarate | Quetiapine Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1018 | Quetiapine Fumarate | Quetiapine Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1018 | Quetiapine Fumarate | Quetiapine Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1018 | Quetiapine Fumarate | Quetiapine Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1018 | Quetiapine Fumarate | Quetiapine Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2175 | Quetiapine Fumarate | Quetiapine Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2175 | Quetiapine Fumarate | Quetiapine Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 71335-1353 | Quetiapine Fumarate | Quetiapine Fumarate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1353 | Quetiapine Fumarate | Quetiapine Fumarate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1353 | Quetiapine Fumarate | Quetiapine Fumarate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1353 | Quetiapine Fumarate | Quetiapine Fumarate | Bryant Ranch Prepack | ANDA | Current |
| 80425-0184 | Quetiapine Fumarate | Quetiapine Fumarate | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0184 | Quetiapine Fumarate | Quetiapine Fumarate | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |