Application 077745
- Type
- ANDA
- Sponsor
- TEVA PHARMS
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 150MG BASE | No | No |
| 005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 200MG BASE | No | No |
| 006 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 300MG BASE | No | No |
| 007 | 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 |
|---|---|---|---|---|---|---|---|
| A077745-001 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A077745-002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A077745-003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A077745-004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A077745-005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A077745-006 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A077745-007 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077745-001 | AB |
| A077745-002 | AB |
| A077745-003 | AB |
| A077745-004 | AB |
| A077745-005 | AB |
| A077745-006 | AB |
| A077745-007 | 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 | A077745-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077745-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077745-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077745-004 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077745-005 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077745-006 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077745-007 | 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 | A077745-001 | 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 | A077745-002 | 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 | A077745-003 | 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 | A077745-004 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET / ORAL | AB | 2012-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077745-005 | 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 | A077745-006 | 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 | A077745-007 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077745-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077745-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077745-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077745-004 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077745-005 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077745-006 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077745-007 | 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 | A077745-001 | 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 | A077745-002 | 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 | A077745-003 | 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 | A077745-004 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET / ORAL | AB | 2012-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077745-005 | 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 | A077745-006 | 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 | A077745-007 | 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 | A077745-001 | 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 | A077745-002 | 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 | A077745-003 | 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 | A077745-004 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET / ORAL | AB | 2012-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077745-005 | 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 | A077745-006 | 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 | A077745-007 | 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 | A077745-001 | 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 | A077745-002 | 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 | A077745-003 | 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 | A077745-004 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET / ORAL | AB | 2012-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077745-005 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077745-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077745-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077745-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077745-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077745-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077745-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077745-007 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077745-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077745-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077745-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077745-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077745-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077745-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077745-007 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077745-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077745-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077745-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077745-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077745-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077745-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077745-007 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077745-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077745-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077745-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077745-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077745-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077745-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077745-007 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077745-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077745-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077745-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077745-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077745-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077745-006 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077745-007 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077745-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077745-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077745-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077745-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077745-005 | AB | 1 | 03ed91905a0d… |
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 | Teva Pharmaceuticals USA, Inc. | c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b | 2025-08-04 | Boxed warning, Warnings, Adverse reactions | 077745 ANDA077745 0093-8166 0093-8165 0093-8163 0093-8162 0093-2063 0093-8164 |
| Quetiapine | QUETIAPINE | Aphena Pharma Solutions - Tennessee, LLC | fdece055-aeb5-43d6-b730-54dd74bde304 | 2023-04-19 | Boxed warning, Warnings, Adverse reactions | 077745 ANDA077745 |
| Quetiapine | QUETIAPINE | Proficient Rx LP | dd6b6088-943e-413b-9886-88dd9c622be4 | 2022-09-01 | Boxed warning, Warnings, Adverse reactions | 077745 ANDA077745 71205-026 |
| Quetiapine | QUETIAPINE | Proficient Rx LP | 6258bbaf-4ac0-4621-b95e-e6b032aa0518 | 2020-02-01 | Boxed warning, Warnings, Adverse reactions | 077745 ANDA077745 71205-402 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-2063 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-2063 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-2063 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-2063 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-2063 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-2063 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-2063 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-2063 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8162 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8162 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8162 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8162 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8162 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8162 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8162 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8162 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8163 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8163 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8163 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8163 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8163 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8163 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8163 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8163 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8164 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8164 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8164 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8164 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8164 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8164 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8164 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8164 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8165 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8165 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8165 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8165 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8165 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8165 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8165 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8165 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8166 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8166 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8166 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8166 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8166 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8166 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8166 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8166 | Quetiapine | Quetiapine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0615-7724 | Quetiapine Fumarate | Quetiapine Fumarate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7725 | Quetiapine Fumarate | Quetiapine Fumarate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7726 | Quetiapine Fumarate | Quetiapine Fumarate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7727 | Quetiapine Fumarate | Quetiapine Fumarate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7728 | Quetiapine Fumarate | Quetiapine Fumarate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7846 | Quetiapine Fumarate | Quetiapine Fumarate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 42291-695 | Quetiapine | Quetiapine | AvKARE | ANDA | Current |
| 42291-696 | Quetiapine | Quetiapine | AvKARE | ANDA | Current |
| 42291-697 | Quetiapine | Quetiapine | AvKARE | ANDA | Current |
| 42291-698 | Quetiapine | Quetiapine | AvKARE | ANDA | Current |
| 42291-699 | Quetiapine | Quetiapine | AvKARE | ANDA | Current |
| 42291-700 | Quetiapine | Quetiapine | AvKARE | ANDA | Current |
| 43353-011 | Quetiapine Fumarate | Quetiapine Fumarate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-955 | Quetiapine Fumarate | Quetiapine Fumarate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-957 | Quetiapine Fumarate | Quetiapine Fumarate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 64725-8166 | Quetiapine Fumarate | Quetiapine Fumarate | TYA Pharmaceuticals | ANDA | Current |
| 71205-026 | Quetiapine | Quetiapine | Proficient Rx LP | ANDA | Current |
| 71205-026 | Quetiapine | Quetiapine | Proficient Rx LP | ANDA | Current |
| 71205-026 | Quetiapine | Quetiapine | Proficient Rx LP | ANDA | Current |
| 71205-026 | Quetiapine | Quetiapine | Proficient Rx LP | ANDA | Current |
| 71205-402 | Quetiapine | Quetiapine | Proficient Rx LP | ANDA | Current |
| 71610-538 | Quetiapine | Quetiapine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31287 | ORIG | 2012-03-29 |