Application 090749
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 50MG BASE | No | No |
| 002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 100MG BASE | No | No |
| 003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 200MG BASE | No | No |
| 004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 300MG BASE | No | No |
| 005 | 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 |
|---|---|---|---|---|---|---|---|
| A090749-001 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A090749-002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A090749-003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A090749-004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A090749-005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090749-001 | AB |
| A090749-002 | AB |
| A090749-003 | AB |
| A090749-004 | AB |
| A090749-005 | 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 | A090749-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090749-002 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090749-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090749-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090749-005 | 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 | A090749-001 | 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 | A090749-002 | 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 | A090749-003 | 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 | A090749-004 | 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 | A090749-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090749-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090749-002 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090749-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090749-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090749-005 | 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 | A090749-001 | 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 | A090749-002 | 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 | A090749-003 | 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 | A090749-004 | 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 | A090749-005 | 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 | A090749-001 | 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 | A090749-002 | 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 | A090749-003 | 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 | A090749-004 | 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 | A090749-005 | 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 | A090749-001 | 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 | A090749-002 | 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 | A090749-003 | 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 | A090749-004 | 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 | A090749-005 | 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 | A090749-001 | 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 | A090749-002 | 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 | A090749-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090749-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090749-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090749-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090749-002 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090749-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090749-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090749-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A090749-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090749-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090749-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090749-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090749-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090749-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090749-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090749-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090749-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090749-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090749-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090749-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090749-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090749-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090749-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090749-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090749-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090749-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090749-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090749-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090749-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090749-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090749-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090749-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090749-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090749-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090749-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090749-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090749-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090749-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090749-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090749-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090749-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090749-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090749-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090749-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090749-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090749-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090749-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090749-005 | AB | 1 | 5bbf6a4d5a75… |
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 | Golden State Medical Supply, Inc. | 6fc9c8e2-6f34-aa43-e053-2a91aa0ac377 | 2025-04-03 | Boxed warning, Warnings, Adverse reactions | 090749 ANDA090749 51407-070 51407-069 51407-068 51407-067 51407-071 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Hikma Pharmaceuticals USA Inc. | 271e9fb7-3c70-43fc-8279-5adf189f3c22 | 2025-02-10 | Boxed warning, Warnings, Adverse reactions | 090749 ANDA090749 0054-0222 0054-0221 0054-0230 0054-0229 0054-0223 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Aphena Pharma Solutions - Tennessee, LLC | 60316ccd-c042-4ea0-9d05-3caf7cc2cab1 | 2021-10-15 | Boxed warning, Warnings, Adverse reactions | 090749 ANDA090749 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0221 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0221 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0221 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0221 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0221 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0221 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0221 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0221 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0221 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0222 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0222 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0222 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0222 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0222 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0222 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0222 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0222 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0222 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0223 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0223 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0223 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0223 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0223 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0223 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0223 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0223 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0223 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0229 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0229 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0229 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0229 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0229 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0229 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0229 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0229 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0229 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0230 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0230 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0230 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0230 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0230 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0230 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0230 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0230 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0054-0230 | Quetiapine Fumarate | Quetiapine Fumarate | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 43353-813 | Quetiapine Fumarate | Quetiapine Fumarate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-2757 | Quetiapine Fumarate | Quetiapine Fumarate | A-S Medication Solutions | ANDA | Current |
| 51407-067 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-067 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-067 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-067 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-067 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply | ANDA | Current |
| 51407-067 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-067 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-068 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-068 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-068 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-068 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-068 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply | ANDA | Current |
| 51407-068 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-068 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-069 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-069 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-069 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-069 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-069 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply | ANDA | Current |
| 51407-069 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-069 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-070 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-070 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-070 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-070 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-070 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply | ANDA | Current |
| 51407-070 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-070 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-071 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-071 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-071 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-071 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-071 | Quetiapine Fumarate | Quetiapine Fumarate | Golden State Medical Supply | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9291 | ORIG | 2012-03-29 |