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 |
|---|---|---|---|---|---|
| 2019-12-14 00:12 UTC | 2019-12 | A090960-005 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A090960-006 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090960-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A090960-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A090960-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A090960-004 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A090960-005 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A090960-006 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090960-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A090960-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A090960-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A090960-004 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A090960-005 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A090960-006 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090960-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090960-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090960-003 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090960-004 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090960-005 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090960-006 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A090960-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A090960-002 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A090960-003 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A090960-004 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A090960-005 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A090960-006 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A090960-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A090960-002 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A090960-003 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A090960-004 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A090960-005 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A090960-006 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090960-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090960-002 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090960-003 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090960-004 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090960-005 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090960-006 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090960-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090960-002 | AB | 1 | 9b2671bbb829… |
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 | Preferred Pharmaceuticals Inc. | 711f42c5-0719-46de-81fb-3d03801b9ed9 | 2026-08-25 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Preferred Pharmaceuticals Inc. | 717b55c4-a23f-4d74-8023-0f4e14d89ec8 | 2026-08-24 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | NuCare Pharmaceuticals,Inc. | 227b8b2b-a238-efb4-e063-6394a90acc7e | 2026-08-17 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | c6c454c4-3eae-48ae-bf17-5dccdb659141 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | d38f0f4e-dc0f-4c92-a212-c4da3db74801 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | 3085f68d-e83c-4f59-b058-8bdae7f4e537 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | b8864cb9-1c6a-4e36-9893-eb1403ee8745 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | ea9b9ed1-4be0-4dc0-b1dd-239caff5253e | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | 02b19885-2987-4c46-8d2a-5e59656f72e8 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | 695415b1-083d-4540-9f41-bde4b201f834 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | c52a9bff-8a03-44f5-9128-799c7dca0467 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 94a81681-381e-4b3b-89ac-e86dcbe7f890 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 3eb39b4e-4c79-43b9-a30e-b4221c0e2bd2 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | fd9cce28-0052-4b0b-8a66-a1615e082d95 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE | Coupler LLC | 5643d339-50ea-405d-e063-6394a90a3b70 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | NorthStar Rx LLC | e6e25ef9-2671-489e-8eca-58bedb4f59ab | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | Quetiapine Fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE | Unit Dose Solutions, Inc. | 55f358e1-9458-b197-e063-6394a90a3f0e | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Unit Dose Solutions, Inc. | 55f574bc-ec55-93e2-e063-6394a90a1d47 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate QUETIAPINE FUMARATE |
| Quetiapine fumarate | QUETIAPINE | Unit Dose Solutions, Inc. | 559fdce5-ab3e-0d02-e063-6394a90a7fbd | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | Quetiapine fumarate |
| Quetiapine fumarate | QUETIAPINE | Unit Dose Solutions, Inc. | 55a5671b-7771-0adf-e063-6294a90acfa6 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 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 |