Application 090960
- Type
- ANDA
- Sponsor
- ZENNOVA
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 |
|---|---|---|---|---|---|---|---|
| A090960-001 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A090960-002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A090960-003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A090960-004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A090960-005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A090960-006 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090960-001 | AB |
| A090960-002 | AB |
| A090960-003 | AB |
| A090960-004 | AB |
| A090960-005 | AB |
| A090960-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090960-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090960-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090960-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090960-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090960-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090960-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A090960-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090960-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090960-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090960-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090960-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090960-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090960-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090960-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090960-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090960-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090960-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090960-006 | 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 | A090960-001 | 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 | A090960-002 | 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 | A090960-003 | 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 | A090960-004 | 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 | A090960-005 | 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 | A090960-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090960-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090960-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090960-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090960-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090960-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090960-006 | 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 | A090960-001 | 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 | A090960-002 | 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 | A090960-003 | 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 | A090960-004 | 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 | A090960-005 | 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 | A090960-006 | 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 | A090960-001 | 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 | A090960-002 | 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 | A090960-003 | 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 | A090960-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090960-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090960-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090960-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090960-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090960-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090960-006 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090960-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090960-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090960-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090960-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090960-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090960-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090960-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090960-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090960-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090960-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090960-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090960-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090960-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090960-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090960-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090960-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090960-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090960-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090960-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090960-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090960-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090960-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090960-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090960-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090960-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090960-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090960-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090960-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090960-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090960-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090960-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090960-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090960-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090960-004 | AB | 1 | b8a1b40f171c… |
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 | Proficient Rx LP | c1f2ccba-62f3-44e7-b06f-dea61eac9e93 | 2023-04-01 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Macleods Pharmaceuticals Limited | 531cbe20-dff2-4983-9788-4543079f83ff | 2023-03-16 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Alembic Pharmaceuticals Limited | 93ab6237-321e-4a2c-b0ca-3fc9acb31f9a | 2023-01-30 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Proficient Rx LP | 1a147d6c-8af8-4379-8a13-1864a9a79b84 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Proficient Rx LP | 8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60 | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Aphena Pharma Solutions - Tennessee, LLC | 60316ccd-c042-4ea0-9d05-3caf7cc2cab1 | 2021-10-15 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Proficient Rx LP | 03517f29-f270-4350-a57a-fbe1967b0096 | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43353-150 | quetiapine fumarate | quetiapine fumarate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-153 | quetiapine fumarate | quetiapine fumarate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-155 | quetiapine fumarate | quetiapine fumarate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-161 | quetiapine fumarate | quetiapine fumarate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-785 | quetiapine fumarate | quetiapine fumarate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-786 | quetiapine fumarate | quetiapine fumarate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-788 | quetiapine fumarate | quetiapine fumarate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-847 | quetiapine fumarate | quetiapine fumarate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-852 | quetiapine fumarate | quetiapine fumarate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-2914 | quetiapine fumarate | quetiapine fumarate | A-S Medication Solutions | ANDA | Current |
| 50090-2932 | quetiapine fumarate | quetiapine fumarate | A-S Medication Solutions | ANDA | Current |
| 50090-2966 | quetiapine fumarate | quetiapine fumarate | A-S Medication Solutions | ANDA | Current |
| 50090-3370 | quetiapine fumarate | quetiapine fumarate | A-S Medication Solutions | ANDA | Current |
| 60429-413 | quetiapine fumarate | quetiapine fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-413 | quetiapine fumarate | quetiapine fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-414 | quetiapine fumarate | quetiapine fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-414 | quetiapine fumarate | quetiapine fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-415 | quetiapine fumarate | quetiapine fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-415 | quetiapine fumarate | quetiapine fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-416 | quetiapine fumarate | quetiapine fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-416 | quetiapine fumarate | quetiapine fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-416 | quetiapine fumarate | quetiapine fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-417 | quetiapine fumarate | quetiapine fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-417 | quetiapine fumarate | quetiapine fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-418 | quetiapine fumarate | quetiapine fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-418 | quetiapine fumarate | quetiapine fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60505-3130 | quetiapine fumarate | quetiapine fumarate | Apotex Corp. | ANDA | Current |
| 60505-3130 | quetiapine fumarate | quetiapine fumarate | Apotex Corp. | ANDA | Current |
| 60505-3131 | quetiapine fumarate | quetiapine fumarate | Apotex Corp. | ANDA | Current |
| 60505-3132 | quetiapine fumarate | quetiapine fumarate | Apotex Corp. | ANDA | Current |
| 60505-3132 | quetiapine fumarate | quetiapine fumarate | Apotex Corp. | ANDA | Current |
| 60505-3133 | quetiapine fumarate | quetiapine fumarate | Apotex Corp. | ANDA | Current |
| 60505-3133 | quetiapine fumarate | quetiapine fumarate | Apotex Corp. | ANDA | Current |
| 60505-3134 | quetiapine fumarate | quetiapine fumarate | Apotex Corp. | ANDA | Current |
| 60505-3135 | quetiapine fumarate | quetiapine fumarate | Apotex Corp. | ANDA | Current |
| 60505-3135 | quetiapine fumarate | quetiapine fumarate | Apotex Corp. | ANDA | Current |
| 60505-3136 | quetiapine fumarate | quetiapine fumarate | Apotex Corp. | ANDA | Current |
| 60505-3137 | quetiapine fumarate | quetiapine fumarate | Apotex Corp. | ANDA | Current |
| 60505-3137 | quetiapine fumarate | quetiapine fumarate | Apotex Corp. | ANDA | Current |
| 60505-3138 | quetiapine fumarate | quetiapine fumarate | Apotex Corp. | ANDA | Current |
| 60505-3139 | quetiapine fumarate | quetiapine fumarate | Apotex Corp. | ANDA | Current |
| 60505-3139 | quetiapine fumarate | quetiapine fumarate | Apotex Corp. | ANDA | Current |
| 70518-0753 | quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0753 | quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1029 | quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1029 | quetiapine fumarate | quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31508 | ORIG | 2012-03-29 |