Application 020058
- Type
- NDA
- Sponsor
- IMMUNEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | THIOPLEX | THIOTEPA | INJECTABLE;INJECTION | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020058-001 | THIOPLEX | THIOTEPA | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 |
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| 2026-07 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020058-001 | THIOPLEX | 15MG/VIAL | INJECTABLE / INJECTION | RLD | 1994-12-22 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020058-001 | THIOPLEX | 15MG/VIAL | INJECTABLE / INJECTION | RLD | 1994-12-22 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N020058-001 | THIOPLEX | 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-12-22 | e64feba35796… |
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 |
|---|---|---|---|---|---|---|
| TEPADINA | THIOTEPA | Amneal Pharmaceuticals LLC | 559e353c-2dc0-16ba-e054-00144ff8d46c | 2026-01-30 | Boxed warning, Warnings, Adverse reactions | THIOTEPA |
| Thiotepa | THIOTEPA | Gland Pharma Limited | 6cd6ae89-c553-4328-9262-4363610a1f19 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | THIOTEPA |
| Thiotepa | THIOTEPA | Sagent Pharmaceuticals | 448c29f1-6d9c-4f8e-8a69-9b85e973e728 | 2025-10-20 | Warnings, Adverse reactions | THIOTEPA |
| TEPYLUTE | THIOTEPA | Shorla Oncology Inc. | add44e98-a042-4e38-b870-beb36693805b | 2025-07-01 | Boxed warning, Warnings, Adverse reactions | THIOTEPA |
| Thiotepa | THIOTEPA | Novadoz Pharmaceuticals LLC | b702dcc9-dd0e-4386-b1e2-f20562fd2ad9 | 2024-04-14 | Boxed warning, Warnings, Adverse reactions | THIOTEPA |
| Thiotepa | THIOTEPA | Meitheal Pharmaceuticals Inc | 4b4725eb-95f1-45cc-852f-152beb5f1e2c | 2023-12-27 | Boxed warning, Warnings, Adverse reactions | THIOTEPA |
| Thiotepa | THIOTEPA | Hikma Pharmaceuticals USA Inc. | 9ae8063c-ba28-4da2-a94c-8e1a5f75e4b3 | 2023-05-31 | Boxed warning, Warnings, Adverse reactions | THIOTEPA |
| Thiotepa | THIOTEPA | Hikma Pharmaceuticals USA Inc. | 6dc898dc-5949-4aa4-83f8-4bd20c29eb93 | 2023-05-24 | Warnings, Adverse reactions | THIOTEPA |
| Thiotepa | THIOTEPA | Dr.Reddy's Laboratories Inc., | a8c8bb14-0423-e4a3-8bf0-8a66ce05b1bb | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | THIOTEPA |
| Thiotepa | THIOTEPA | Fresenius Kabi USA, LLC | 493410f3-0733-4f76-8050-6529d96f2a5b | 2022-03-28 | Boxed warning, Warnings, Adverse reactions | THIOTEPA |
| Thiotepa | THIOTEPA | Hikma Pharmaceuticals USA Inc. | b19b03db-471d-4ee7-b1b8-6eccc39c41b0 | 2021-04-02 | Warnings, Adverse reactions | THIOTEPA |
| Thiotepa | THIOTEPA | Dr.Reddy's Laboratories Inc., | 0def6a5e-4bf5-b1fd-47b7-0f17ecfd9bc2 | 2018-04-25 | Warnings, Adverse reactions | THIOTEPA |