Application 202152
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
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 |
|---|---|---|---|---|---|---|---|
| A202152-001 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A202152-002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A202152-003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A202152-004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A202152-005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A202152-006 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202152-001 | AB |
| A202152-002 | AB |
| A202152-003 | AB |
| A202152-004 | AB |
| A202152-005 | AB |
| A202152-006 | 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 | A202152-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202152-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202152-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202152-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202152-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202152-006 | 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 | A202152-001 | 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 | A202152-002 | 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 | A202152-003 | 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 | A202152-004 | 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 | A202152-005 | 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 | A202152-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-006 | 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 | A202152-001 | 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 | A202152-002 | 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 | A202152-003 | 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 | A202152-004 | 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 | A202152-005 | 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 | A202152-006 | 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 | A202152-001 | 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 | A202152-002 | 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 | A202152-003 | 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 | A202152-004 | 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 | A202152-005 | 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 | A202152-006 | 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 | A202152-001 | 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 | A202152-002 | 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 | A202152-003 | 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 | A202152-004 | 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 | A202152-005 | 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 | A202152-006 | 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 | A202152-001 | 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 | A202152-002 | 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 | A202152-003 | 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 | A202152-004 | 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 | A202152-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202152-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202152-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202152-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202152-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202152-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202152-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202152-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202152-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202152-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202152-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202152-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202152-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202152-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202152-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202152-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202152-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202152-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202152-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202152-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202152-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202152-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202152-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202152-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202152-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202152-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202152-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202152-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202152-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202152-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202152-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202152-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202152-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202152-004 | 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 | QUETIAPINE | Bryant Ranch Prepack | cb989abf-7d73-4ab9-a07f-a8c9de50389f | 2026-04-03 | Boxed warning, Warnings, Adverse reactions | 202152 ANDA202152 63629-7116 |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | Bryant Ranch Prepack | a45d8b77-f13d-41c5-8d50-15152fc6f85c | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | 202152 ANDA202152 63629-4841 |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 4e1e5249-1cb7-4cc2-ad5a-cdeeee2f494f | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | 202152 ANDA202152 63629-4964 |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 45c4c3a4-3acc-413e-9746-4816d513fac6 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | 202152 ANDA202152 63629-4776 |
| Quetiapine | QUETIAPINE | Accord Healthcare Inc. | 2d77412a-e084-4406-ac33-d882aece9354 | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | 202152 ANDA202152 16729-150 16729-149 |
| Quetiapine | QUETIAPINE | Proficient Rx LP | 7a090720-fd90-4976-9aa2-41812106eb70 | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | 202152 ANDA202152 |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Proficient Rx LP | 1a147d6c-8af8-4379-8a13-1864a9a79b84 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | 202152 ANDA202152 63187-452 |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Proficient Rx LP | 8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60 | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | 202152 ANDA202152 63187-269 63187-219 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16729-149 | Quetiapine | Quetiapine | Accord Healthcare Inc. | ANDA | Current |
| 16729-150 | Quetiapine | Quetiapine | Accord Healthcare Inc. | ANDA | Current |
| 16729-150 | Quetiapine | Quetiapine | Accord Healthcare Inc. | ANDA | Current |
| 16729-150 | Quetiapine | Quetiapine | Accord Healthcare Inc. | ANDA | Current |
| 16729-150 | Quetiapine | Quetiapine | Accord Healthcare Inc. | ANDA | Current |
| 16729-150 | Quetiapine | Quetiapine | Accord Healthcare Inc. | ANDA | Current |
| 50090-2307 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-2307 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-2307 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-2307 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-2338 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-2338 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-2338 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-2689 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-2689 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-2689 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-2690 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-2830 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-2830 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-2831 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-2831 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-2831 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-3749 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-3749 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-3749 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-3749 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-4788 | Quetiapine | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50436-6338 | QUETIAPINE FUMARATE | Quetiapine | Unit Dose Services | ANDA | Current |
| 50436-6339 | QUETIAPINE FUMARATE | Quetiapine | Unit Dose Services | ANDA | Current |
| 53002-1516 | Quetiapine | Quetiapine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1529 | Quetiapine | Quetiapine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1529 | Quetiapine | Quetiapine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 61919-084 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | Direct_Rx | ANDA | Current |
| 61919-084 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | Direct_Rx | ANDA | Current |
| 61919-084 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | Direct_Rx | ANDA | Current |
| 61919-084 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | Direct_Rx | ANDA | Current |
| 61919-519 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | Direct RX | ANDA | Current |
| 61919-911 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | DIRECT RX | ANDA | Current |
| 61919-911 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | DIRECT RX | ANDA | Current |
| 61919-911 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | DIRECT RX | ANDA | Current |
| 63187-219 | Quetiapine fumarate | Quetiapine fumarate | Proficient Rx LP | ANDA | Current |
| 63187-219 | Quetiapine fumarate | Quetiapine fumarate | Proficient Rx LP | ANDA | Current |
| 63187-219 | Quetiapine fumarate | Quetiapine fumarate | Proficient Rx LP | ANDA | Current |
| 63187-219 | Quetiapine fumarate | Quetiapine fumarate | Proficient Rx LP | ANDA | Current |
| 63187-269 | Quetiapine fumarate | Quetiapine fumarate | Proficient Rx LP | ANDA | Current |
| 63187-269 | Quetiapine fumarate | Quetiapine fumarate | Proficient Rx LP | ANDA | Current |
| 63187-269 | Quetiapine fumarate | Quetiapine fumarate | Proficient Rx LP | ANDA | Current |
| 63187-269 | Quetiapine fumarate | Quetiapine fumarate | Proficient Rx LP | ANDA | Current |
| 63187-452 | Quetiapine fumarate | Quetiapine fumarate | Proficient Rx LP | ANDA | Current |
| 63187-452 | Quetiapine fumarate | Quetiapine fumarate | Proficient Rx LP | ANDA | Current |
| 63187-452 | Quetiapine fumarate | Quetiapine fumarate | Proficient Rx LP | ANDA | Current |
| 63629-4745 | Quetiapine fumarate | quetiapine fumarate | Bryant Ranch Prepack | ANDA | Current |
| 63629-4776 | Quetiapine fumarate | Quetiapine fumarate | Bryant Ranch Prepack | ANDA | Current |
| 63629-4776 | Quetiapine fumarate | Quetiapine fumarate | Bryant Ranch Prepack | ANDA | Current |
| 63629-4841 | Quetiapine Fumarate | Quetiapine Fumarate | Bryant Ranch Prepack | ANDA | Current |
| 63629-4841 | Quetiapine Fumarate | Quetiapine Fumarate | Bryant Ranch Prepack | ANDA | Current |
| 63629-4939 | QUETIAPINE FUMARATE | Quetiapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-4939 | QUETIAPINE FUMARATE | Quetiapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-4939 | QUETIAPINE FUMARATE | Quetiapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-4964 | Quetiapine fumarate | Quetiapine fumarate | Bryant Ranch Prepack | ANDA | Current |
| 63629-4964 | QUETIAPINE FUMARATE | quetiapine fumarate | Bryant Ranch Prepack | ANDA | Current |
| 63629-7116 | QUETIAPINE FUMARATE | Quetiapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-7116 | Quetiapine | Quetiapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-7116 | QUETIAPINE FUMARATE | Quetiapine | Bryant Ranch Prepack | ANDA | Current |
| 64725-0145 | Quetiapine fumarate | Quetiapine fumarate | TYA Pharmaceuticals | ANDA | Current |
| 64725-0147 | Quetiapine fumarate | Quetiapine fumarate | TYA Pharmaceuticals | ANDA | Current |
| 64725-0148 | Quetiapine fumarate | Quetiapine fumarate | TYA Pharmaceuticals | ANDA | Current |
| 64725-0149 | Quetiapine fumarate | Quetiapine fumarate | TYA Pharmaceuticals | ANDA | Current |
| 67046-361 | Quetiapine | Quetiapine | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-620 | Quetiapine | Quetiapine | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-621 | Quetiapine | Quetiapine | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-622 | Quetiapine | Quetiapine | Contract Pharmacy Services-PA | ANDA | Current |
| 68071-2038 | Quetiapine | Quetiapine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4161 | Quetiapine | Quetiapine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4161 | Quetiapine | Quetiapine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4161 | Quetiapine | Quetiapine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7184 | Quetiapine | Quetiapine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7184 | Quetiapine | Quetiapine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7184 | Quetiapine | Quetiapine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7185 | Quetiapine | Quetiapine | Preferred Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9974 | ORIG | 2012-03-30 |