Application 201109
- Type
- ANDA
- Sponsor
- LUPIN 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 |
|---|---|---|---|---|---|---|---|
| A201109-001 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A201109-002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A201109-003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A201109-004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A201109-005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A201109-006 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A201109-001 | AB |
| A201109-002 | AB |
| A201109-003 | AB |
| A201109-004 | AB |
| A201109-005 | AB |
| A201109-006 | 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 | A201109-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201109-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201109-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201109-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201109-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201109-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201109-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201109-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201109-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201109-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201109-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201109-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201109-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201109-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201109-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201109-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201109-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201109-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201109-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201109-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201109-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201109-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201109-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201109-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201109-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201109-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201109-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201109-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201109-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201109-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201109-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201109-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201109-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201109-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201109-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201109-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201109-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201109-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201109-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201109-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 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 | A201109-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201109-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201109-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201109-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201109-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201109-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201109-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201109-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201109-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201109-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201109-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201109-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A201109-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201109-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201109-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201109-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201109-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201109-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201109-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201109-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201109-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201109-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201109-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201109-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201109-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201109-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201109-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201109-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201109-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201109-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201109-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201109-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201109-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201109-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201109-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201109-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201109-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201109-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201109-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201109-004 | 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. | c6c454c4-3eae-48ae-bf17-5dccdb659141 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | 201109 ANDA201109 70518-2901 |
| Quetiapine fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | d38f0f4e-dc0f-4c92-a212-c4da3db74801 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 201109 ANDA201109 70518-2752 |
| Quetiapine fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | ea9b9ed1-4be0-4dc0-b1dd-239caff5253e | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | 201109 ANDA201109 70518-2102 |
| Quetiapine fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | 02b19885-2987-4c46-8d2a-5e59656f72e8 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | 201109 ANDA201109 70518-1918 |
| Quetiapine fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | 695415b1-083d-4540-9f41-bde4b201f834 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 201109 ANDA201109 70518-1919 |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 94a81681-381e-4b3b-89ac-e86dcbe7f890 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 201109 ANDA201109 |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | fd9cce28-0052-4b0b-8a66-a1615e082d95 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 201109 ANDA201109 |
| Quetiapine fumarate | QUETIAPINE | Coupler LLC | 5643d339-50ea-405d-e063-6394a90a3b70 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 201109 ANDA201109 |
| Quetiapine fumarate | QUETIAPINE | Unit Dose Solutions, Inc. | 55f358e1-9458-b197-e063-6394a90a3f0e | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 201109 ANDA201109 |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Unit Dose Solutions, Inc. | 55f574bc-ec55-93e2-e063-6394a90a1d47 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 201109 ANDA201109 |
| Quetiapine fumarate | QUETIAPINE | Unit Dose Solutions, Inc. | 559fdce5-ab3e-0d02-e063-6394a90a7fbd | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 201109 ANDA201109 |
| Quetiapine fumarate | QUETIAPINE | Unit Dose Solutions, Inc. | 55a5671b-7771-0adf-e063-6294a90acfa6 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 201109 ANDA201109 |
| Quetiapine fumarate | QUETIAPINE FUMARATE | St. Mary's Medical Park Pharmacy | 36248b77-277c-7d66-e063-6394a90ae1e8 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 201109 ANDA201109 |
| Quetiapine fumarate | QUETIAPINE | Coupler LLC | 544f6e91-e61f-c57a-e063-6294a90af9d1 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | 201109 ANDA201109 |
| Quetiapine fumarate | QUETIAPINE FUMARATE | St. Mary's Medical Park Pharmacy | 3624100f-6e3f-a2ad-e063-6294a90a0fc0 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | 201109 ANDA201109 |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Lupin Pharmaceuticals, Inc. | a951cd63-d329-47c9-965a-582fa73a07c6 | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | 201109 ANDA201109 68180-447 68180-449 68180-448 68180-450 68180-446 68180-445 |
| Quetiapine fumarate | QUETIAPINE | Coupler LLC | 533154bb-a596-c88b-e063-6294a90a8956 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 201109 ANDA201109 |
| Quetiapine fumarate | QUETIAPINE | Coupler LLC | 52ba669d-c846-03c2-e063-6394a90ac0f0 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | 201109 ANDA201109 |
| Quetiapine fumarate | QUETIAPINE | American Health Packaging | 9f927ae2-a0ae-4953-99ba-8de59ee5bfca | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 201109 ANDA201109 |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Quallent Pharmaceuticals Health LLC | d51c5bf6-950d-493b-be55-de575c5ef2e7 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | 201109 ANDA201109 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68001-185 | Quetiapine fumarate | quetiapine | BluePoint Laboratories | ANDA | Current |
| 68001-185 | Quetiapine fumarate | quetiapine | BluePoint Laboratories | ANDA | Current |
| 68001-185 | Quetiapine fumarate | quetiapine | BluePoint Laboratories | ANDA | Current |
| 68001-185 | Quetiapine fumarate | quetiapine | BluePoint Laboratories | ANDA | Current |
| 68001-185 | Quetiapine fumarate | quetiapine | BluePoint Laboratories | ANDA | Current |
| 68180-445 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-445 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-445 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-445 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-445 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-446 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-446 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-446 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-446 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-446 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-447 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-447 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-447 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-447 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-447 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-448 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-448 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-448 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-448 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-448 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-449 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-449 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-449 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-449 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-449 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-450 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-450 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-450 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-450 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-450 | Quetiapine fumarate | quetiapine fumarate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 70518-1918 | Quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1918 | Quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1918 | Quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1919 | Quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1919 | Quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2102 | Quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2102 | Quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2102 | Quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2102 | Quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2102 | Quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2752 | Quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2752 | Quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2752 | Quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2752 | Quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2901 | Quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2901 | Quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3190 | Quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |