Application 091388
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
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 |
|---|---|---|---|---|---|---|---|
| A091388-001 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A091388-002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A091388-003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A091388-004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A091388-005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A091388-006 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A091388-007 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091388-001 | AB |
| A091388-002 | AB |
| A091388-003 | AB |
| A091388-004 | AB |
| A091388-005 | AB |
| A091388-006 | AB |
| A091388-007 | 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 | A091388-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091388-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091388-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091388-004 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091388-005 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091388-006 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091388-007 | 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 | A091388-001 | 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 | A091388-002 | 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 | A091388-003 | 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 | A091388-004 | 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 | A091388-005 | 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 | A091388-006 | 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 | A091388-007 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091388-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091388-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091388-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091388-004 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091388-005 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091388-006 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091388-007 | 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 | A091388-001 | 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 | A091388-002 | 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 | A091388-003 | 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 | A091388-004 | 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 | A091388-005 | 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 | A091388-006 | 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 | A091388-007 | 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 | A091388-001 | 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 | A091388-002 | 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 | A091388-003 | 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 | A091388-004 | 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 | A091388-005 | 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 | A091388-006 | 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 | A091388-007 | 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 | A091388-001 | 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 | A091388-002 | 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 | A091388-003 | 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 | A091388-004 | 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 | A091388-005 | 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 | A091388-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091388-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091388-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091388-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091388-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091388-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091388-007 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091388-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091388-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091388-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091388-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091388-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091388-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091388-007 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091388-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091388-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091388-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091388-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091388-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091388-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091388-007 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091388-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091388-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091388-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091388-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091388-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091388-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091388-007 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091388-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091388-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091388-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091388-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091388-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091388-006 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091388-007 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091388-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091388-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091388-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091388-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091388-005 | 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 Fumarate | QUETIAPINE FUMARATE | NorthStar Rx LLC | e6e25ef9-2671-489e-8eca-58bedb4f59ab | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | 091388 ANDA091388 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | b90390d8-6ebc-48b3-8b4d-6a3ff7d19ef6 | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | 091388 ANDA091388 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 58541ffd-58c3-49aa-ad90-7e91a3c0b7d6 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 091388 ANDA091388 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | d3dcfb51-e67d-44dc-9186-4729f6414bf1 | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | 091388 ANDA091388 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | aa0d27fd-569a-4573-b45d-2de5f5a30294 | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | 091388 ANDA091388 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 897184b1-de3c-4d59-91be-3069325fd5b2 | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | 091388 ANDA091388 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | da5c118f-404c-4453-aa10-a8656b1d7501 | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | 091388 ANDA091388 70518-3609 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | 911bf26c-a89a-4ce1-8ff5-cfda03d0a482 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 091388 ANDA091388 70518-3581 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | f0ad842c-a0c2-4855-a55b-353b5338980f | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | 091388 ANDA091388 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | 41dbd5a5-4ae2-4ac1-8135-0fdac5c170b5 | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 091388 ANDA091388 70518-3429 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | A-S Medication Solutions | 55018271-1f8f-4683-afee-8203c3bd9acc | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | 091388 ANDA091388 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Rising Pharma Holdings, Inc. | 532c8ace-4cf5-4a08-bae7-2af8c41ffa3d | 2025-10-28 | Boxed warning, Warnings, Adverse reactions | 091388 ANDA091388 16571-718 16571-719 16571-721 16571-720 16571-722 16571-717 16571-809 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Coupler LLC | 3eed13b8-7464-3720-e063-6294a90a1245 | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | 091388 ANDA091388 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 49ebd00b-e0a2-45c3-9cff-4b94d1a6b5ad | 2025-09-11 | Boxed warning, Warnings, Adverse reactions | 091388 ANDA091388 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Aurobindo Pharma Limited | 8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b6 | 2025-09-11 | Boxed warning, Warnings, Adverse reactions | 091388 ANDA091388 65862-493 65862-489 65862-491 65862-494 65862-490 65862-495 65862-492 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Preferred Pharmaceuticals Inc. | 951a098a-d905-4723-89e1-71bf1551dcb6 | 2025-04-11 | Boxed warning, Warnings, Adverse reactions | 091388 ANDA091388 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Direct_Rx | face6c19-3dd9-b188-e053-6294a90a62d0 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 091388 ANDA091388 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Direct_Rx | fceb9f47-8da7-7138-e053-6294a90a5558 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 091388 ANDA091388 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Preferred Pharmaceuticals Inc. | 8acc0ed3-6e4f-4799-8252-5a163938fddc | 2025-01-16 | Boxed warning, Warnings, Adverse reactions | 091388 ANDA091388 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | NuCare Pharmaceuticals,Inc. | 0fdbe32f-d04a-5666-e063-6294a90a8e36 | 2024-01-26 | Boxed warning, Warnings, Adverse reactions | 091388 ANDA091388 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16571-717 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-717 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-717 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-718 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-718 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-718 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-719 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-719 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-719 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-720 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-720 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-720 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-721 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-721 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-721 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-722 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-722 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-722 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-809 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-809 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-809 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 48433-324 | Quetiapine Fumarate | Quetiapine Fumarate | Safecor Health, LLC | ANDA | Current |
| 57237-079 | Quetiapine Fumarate | Quetiapine Fumarate | Citron Pharma LLC | ANDA | Current |
| 57237-080 | Quetiapine Fumarate | Quetiapine Fumarate | Citron Pharma LLC | ANDA | Current |
| 57237-081 | Quetiapine Fumarate | Quetiapine Fumarate | Citron Pharma LLC | ANDA | Current |
| 57237-082 | Quetiapine Fumarate | Quetiapine Fumarate | Citron Pharma LLC | ANDA | Current |
| 57237-083 | Quetiapine Fumarate | Quetiapine Fumarate | Citron Pharma LLC | ANDA | Current |
| 57237-084 | Quetiapine Fumarate | Quetiapine Fumarate | Citron Pharma LLC | ANDA | Current |
| 65862-489 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-489 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-489 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-489 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-489 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-489 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-489 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-490 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-490 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-490 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-490 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-490 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-490 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-490 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-491 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-491 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-491 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-491 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-491 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-491 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-491 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-492 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-492 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-492 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-492 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-492 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-492 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-492 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-493 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-493 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-493 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-493 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-493 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-493 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-493 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-494 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-494 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-494 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-494 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-494 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-494 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-494 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-495 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-495 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-495 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-495 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-495 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-495 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-495 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 70518-3429 | Quetiapine Fumarate | Quetiapine Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3581 | Quetiapine Fumarate | Quetiapine Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3609 | Quetiapine Fumarate | Quetiapine Fumarate | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9336 | ORIG | 2012-03-30 |