Application 088004
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | Yes |
| 002 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 003 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 004 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A088004-001 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | |
| A088004-002 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | ||
| A088004-003 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | ||
| A088004-004 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 |
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 | A088004-001 | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A088004-002 | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A088004-003 | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A088004-004 | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A088004-001 | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A088004-002 | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A088004-003 | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A088004-004 | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A088004-001 | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A088004-002 | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A088004-003 | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A088004-004 | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088004-001 | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088004-002 | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088004-003 | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088004-004 | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A088004-001 | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A088004-002 | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A088004-003 | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A088004-004 | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088004-001 | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088004-002 | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088004-003 | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088004-004 | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088004-001 | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088004-002 | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088004-003 | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088004-004 | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088004-001 | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088004-002 | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088004-003 | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088004-004 | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088004-001 | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088004-002 | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088004-003 | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088004-004 | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088004-001 | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088004-002 | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088004-003 | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088004-004 | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2020-12-22 03:56 UTC | 2020-12 | A088004-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A088004-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A088004-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A088004-004 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A088004-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A088004-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A088004-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A088004-004 | AB | 1 | c0c555d07b60… |
| 2019-09-15 20:21 UTC | 2019-09 | A088004-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A088004-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A088004-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A088004-004 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A088004-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A088004-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A088004-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A088004-004 | AB | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Thioridazine Hydrochloride | THIORIDAZINE HYDROCHLORIDE | Safecor Health LLC | 1fd16a99-e856-4a37-9dae-c443714fac14 | 2026-03-02 | Boxed warning, Warnings, Adverse reactions | 088004 ANDA088004 |
| Thioridazine Hydrochloride | THIORIDAZINE HYDROCHLORIDE | Mylan Institutional Inc. | 52fea941-0b47-41c1-b00d-f88150e8ab93 | 2025-11-11 | Boxed warning, Warnings, Adverse reactions | 088004 ANDA088004 51079-566 51079-565 51079-567 51079-580 |
| Thioridazine Hydrochloride | THIORIDAZINE HYDROCHLORIDE | Mylan Pharmaceuticals Inc. | 56b3f4c2-52af-4947-b225-6808ae9f26f5 | 2025-01-15 | Boxed warning, Warnings, Adverse reactions | 088004 ANDA088004 0378-0618 0378-0612 0378-0616 0378-0614 |
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 |
|---|---|---|---|---|---|
| 0378-0612 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0612 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0612 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0614 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0614 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0614 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0616 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0616 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0616 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0618 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0618 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0618 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 51079-565 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-565 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-565 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-566 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-566 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-566 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-567 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-567 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-567 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-580 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-580 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-580 | Thioridazine Hydrochloride | thioridazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 70518-0770 | Thioridazine Hydrochloride | thioridazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0770 | Thioridazine Hydrochloride | thioridazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0770 | Thioridazine Hydrochloride | thioridazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1706 | Thioridazine Hydrochloride | thioridazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1706 | Thioridazine Hydrochloride | thioridazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1706 | Thioridazine Hydrochloride | thioridazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1706 | Thioridazine Hydrochloride | thioridazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |