Application 208781
- Type
- ANDA
- Sponsor
- PRINSTON INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 50MG BASE | No | No |
| 002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | No | No |
| 003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 200MG BASE | No | No |
| 004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 300MG BASE | No | No |
| 005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 400MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208781-001 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | |
| A208781-002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | |
| A208781-003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | |
| A208781-004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | |
| A208781-005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-03-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208781-001 | AB |
| A208781-002 | AB |
| A208781-003 | AB |
| A208781-004 | AB |
| A208781-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A208781-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A208781-002 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A208781-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A208781-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A208781-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-03-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208781-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208781-002 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208781-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208781-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208781-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-03-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208781-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208781-002 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208781-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208781-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208781-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-03-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208781-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208781-002 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208781-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208781-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208781-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-03-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208781-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208781-002 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208781-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208781-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208781-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-03-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208781-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208781-002 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208781-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208781-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208781-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-03-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208781-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208781-002 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208781-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208781-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208781-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-03-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208781-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208781-002 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208781-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208781-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-04-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208781-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-03-11 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A208781-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208781-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208781-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208781-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208781-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A208781-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208781-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208781-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208781-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208781-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208781-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208781-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208781-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208781-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208781-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208781-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208781-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208781-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208781-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208781-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208781-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208781-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208781-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208781-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208781-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208781-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208781-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208781-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208781-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208781-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208781-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208781-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208781-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208781-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208781-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208781-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208781-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208781-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208781-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208781-005 | AB | 1 | 2680178bc6a6… |
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 | Solco Healthcare U.S., LLC | b0cce89c-0e84-4f60-8e50-0e26c41c2613 | 2023-10-31 | Boxed warning, Warnings, Adverse reactions | 208781 ANDA208781 43547-021 43547-022 43547-020 43547-019 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43547-019 | QUETIAPINE | quetiapine | Solco Healthcare U.S., LLC | ANDA | Current |
| 43547-020 | QUETIAPINE | quetiapine | Solco Healthcare U.S., LLC | ANDA | Current |
| 43547-021 | QUETIAPINE | quetiapine | Solco Healthcare U.S., LLC | ANDA | Current |
| 43547-022 | QUETIAPINE | quetiapine | Solco Healthcare U.S., LLC | ANDA | Current |