Application 216984
- Type
- NDA
- Sponsor
- SHORLA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TEPYLUTE | THIOTEPA | SOLUTION;INTRAVENOUS | 15MG/1.5ML (10MG/ML) | Yes | Yes |
| 002 | TEPYLUTE | THIOTEPA | SOLUTION;INTRAVENOUS | 100MG/10ML (10MG/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N216984-001 | TEPYLUTE | THIOTEPA | 15MG/1.5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-06-25 | |
| N216984-002 | TEPYLUTE | THIOTEPA | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-26 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N216984-001 | 11975013 | 2041-08-16 | Drug product | 2024-07-25 | |
| N216984-001 | 12622921 | 2041-08-16 | U-4530 | 2026-06-10 | |
| N216984-002 | 11975013 | 2041-08-16 | Drug product | 2025-03-07 | |
| N216984-002 | 12622921 | 2041-08-16 | U-4530 | 2026-06-10 |
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 | N216984-001 | TEPYLUTE | 15MG/1.5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-06-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N216984-002 | TEPYLUTE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-26 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N216984-001 | TEPYLUTE | 15MG/1.5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-06-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N216984-002 | TEPYLUTE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-26 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216984-001 | TEPYLUTE | 15MG/1.5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-06-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216984-002 | TEPYLUTE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216984-001 | TEPYLUTE | 15MG/1.5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-06-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216984-002 | TEPYLUTE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216984-001 | TEPYLUTE | 15MG/1.5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-06-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216984-002 | TEPYLUTE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216984-001 | TEPYLUTE | 15MG/1.5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-06-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216984-001 | TEPYLUTE | 15MG/1.5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-06-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216984-001 | TEPYLUTE | 15MG/1.5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-06-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216984-001 | TEPYLUTE | 15MG/1.5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-06-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216984-001 | TEPYLUTE | 15MG/1.5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-06-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216984-001 | TEPYLUTE | 15MG/1.5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-06-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216984-001 | TEPYLUTE | 15MG/1.5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-06-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216984-001 | TEPYLUTE | 15MG/1.5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-06-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N216984-001 | TEPYLUTE | 15MG/1.5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-06-25 | 301d65b070ca… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N216984-001 | TEPYLUTE | 15MG/1.5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-06-25 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N216984-002 | TEPYLUTE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-26 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N216984-001 | 11975013 | 2041-08-16 | Drug product | 2024-07-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N216984-001 | 12622921 | 2041-08-16 | U-4530 | 2026-06-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N216984-002 | 11975013 | 2041-08-16 | Drug product | 2025-03-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N216984-002 | 12622921 | 2041-08-16 | U-4530 | 2026-06-10 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N216984-001 | 11975013 | 2041-08-16 | Drug product | 2024-07-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N216984-001 | 12622921 | 2041-08-16 | U-4530 | 2026-06-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N216984-002 | 11975013 | 2041-08-16 | Drug product | 2025-03-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N216984-002 | 12622921 | 2041-08-16 | U-4530 | 2026-06-10 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216984-001 | 11975013 | 2041-08-16 | Drug product | 2024-07-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216984-002 | 11975013 | 2041-08-16 | Drug product | 2025-03-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216984-001 | 11975013 | 2041-08-16 | Drug product | 2024-07-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216984-002 | 11975013 | 2041-08-16 | Drug product | 2025-03-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216984-001 | 11975013 | 2041-08-16 | Drug product | 2024-07-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216984-002 | 11975013 | 2041-08-16 | Drug product | 2025-03-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216984-001 | 11975013 | 2041-08-16 | Drug product | 2024-07-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216984-002 | 11975013 | 2041-08-16 | Drug product | 2025-03-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216984-001 | 11975013 | 2041-08-16 | Drug product | 2024-07-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216984-001 | 11975013 | 2041-08-16 | Drug product | 2024-07-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216984-001 | 11975013 | 2041-08-16 | Drug product | 2024-07-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216984-001 | 11975013 | 2041-08-16 | Drug product | 2024-07-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216984-001 | 11975013 | 2041-08-16 | Drug product | 2024-07-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216984-001 | 11975013 | 2041-08-16 | Drug product | 2024-07-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216984-001 | 11975013 | 2041-08-16 | Drug product | 2024-07-25 | 79d66fd596c7… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N216984-001 | 11975013 | 2041-08-16 | Drug product | 2024-07-25 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N216984-001 | 12622921 | 2041-08-16 | U-4530 | 2026-06-10 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N216984-002 | 11975013 | 2041-08-16 | Drug product | 2025-03-07 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N216984-002 | 12622921 | 2041-08-16 | U-4530 | 2026-06-10 | a50c72e98297… |
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 |
| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.