Application 022445
- Type
- NDA
- Sponsor
- HERON THERAPS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SUSTOL | GRANISETRON | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | 10MG/0.4ML (10MG/0.4ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022445-001 | SUSTOL | GRANISETRON | 10MG/0.4ML (10MG/0.4ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2016-08-09 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N022445-001 | SUSTOL | 10MG/0.4ML (10MG/0.4ML) | INJECTION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2016-08-09 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N022445-001 | SUSTOL | 10MG/0.4ML (10MG/0.4ML) | INJECTION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2016-08-09 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022445-001 | SUSTOL | 10MG/0.4ML (10MG/0.4ML) | INJECTION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2016-08-09 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N022445-001 | SUSTOL | 10MG/0.4ML (10MG/0.4ML) | INJECTABLE / SUBCUTANEOUS | RLD, RS | 2016-08-09 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022445-001 | 10357570 | 2024-09-28 | U-2253 | 2019-07-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022445-001 | 8252304 | 2024-09-28 | Drug product | 2016-08-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022445-001 | 8252305 | 2024-09-28 | U-1891 | 2016-08-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022445-001 | 8715710 | 2024-09-28 | Drug product | 2016-08-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022445-001 | 9913910 | 2024-09-28 | U-2253 | 2018-03-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022445-001 | 10357570 | 2024-09-28 | U-2253 | 2019-07-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022445-001 | 8252304 | 2024-09-28 | Drug product | 2016-08-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022445-001 | 8252305 | 2024-09-28 | U-1891 | 2016-08-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022445-001 | 8715710 | 2024-09-28 | Drug product | 2016-08-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022445-001 | 9913910 | 2024-09-28 | U-2253 | 2018-03-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022445-001 | 10357570 | 2024-09-28 | U-2253 | 2019-07-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022445-001 | 8252304 | 2024-09-28 | Drug product | 2016-08-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022445-001 | 8252305 | 2024-09-28 | U-1891 | 2016-08-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022445-001 | 8715710 | 2024-09-28 | Drug product | 2016-08-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022445-001 | 9913910 | 2024-09-28 | U-2253 | 2018-03-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022445-001 | 10357570 | 2024-09-28 | U-2253 | 2019-07-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022445-001 | 8252304 | 2024-09-28 | Drug product | 2016-08-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022445-001 | 8252305 | 2024-09-28 | U-1891 | 2016-08-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022445-001 | 8715710 | 2024-09-28 | Drug product | 2016-08-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022445-001 | 9913910 | 2024-09-28 | U-2253 | 2018-03-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022445-001 | 10357570 | 2024-09-28 | U-2253 | 2019-07-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022445-001 | 8252304 | 2024-09-28 | Drug product | 2016-08-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022445-001 | 8252305 | 2024-09-28 | U-1891 | 2016-08-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022445-001 | 8715710 | 2024-09-28 | Drug product | 2016-08-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022445-001 | 9913910 | 2024-09-28 | U-2253 | 2018-03-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022445-001 | 10357570 | 2024-09-28 | U-2253 | 2019-07-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022445-001 | 8252304 | 2024-09-28 | Drug product | 2016-08-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022445-001 | 8252305 | 2024-09-28 | U-1891 | 2016-08-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022445-001 | 8715710 | 2024-09-28 | Drug product | 2016-08-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022445-001 | 9913910 | 2024-09-28 | U-2253 | 2018-03-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022445-001 | 10357570 | 2024-09-28 | U-2253 | 2019-07-25 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022445-001 | 8252304 | 2024-09-28 | Drug product | 2016-08-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022445-001 | 8252305 | 2024-09-28 | U-1891 | 2016-08-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022445-001 | 8715710 | 2024-09-28 | Drug product | 2016-08-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022445-001 | 9913910 | 2024-09-28 | U-2253 | 2018-03-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022445-001 | 10357570 | 2024-09-28 | U-2253 | 2019-07-25 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022445-001 | 8252304 | 2024-09-28 | Drug product | 2016-08-31 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022445-001 | 8252305 | 2024-09-28 | U-1891 | 2016-08-31 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022445-001 | 8715710 | 2024-09-28 | Drug product | 2016-08-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022445-001 | 9913910 | 2024-09-28 | U-2253 | 2018-03-28 | 1e350fbaab3a… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N022445-001 | NDF | 2019-08-09 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N022445-001 | NDF | 2019-08-09 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022445-001 | NDF | 2019-08-09 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022445-001 | NDF | 2019-08-09 | 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 |
|---|---|---|---|---|---|---|
| SUSTOL | GRANISETRON | Heron Therapeutics, Inc. | f7c7ffdd-8270-4030-bc1e-a1cb28a6de56 | 2026-04-30 | Warnings, Adverse reactions | 022445 NDA022445 47426-101 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.