Application 216018
- Type
- NDA
- Sponsor
- SUN PHARMA GLOBAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ASPRUZYO SPRINKLE | RANOLAZINE | GRANULE;EXTENDED RELEASE | 500MG | No | No |
| 002 | ASPRUZYO SPRINKLE | RANOLAZINE | GRANULE;EXTENDED RELEASE | 1000MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N216018-001 | ASPRUZYO SPRINKLE | RANOLAZINE | 500MG | GRANULE, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | |
| N216018-002 | ASPRUZYO SPRINKLE | RANOLAZINE | 1GM | GRANULE, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | |
| N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | |
| N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | |
| N216018-002 | 12161761 | 2038-01-24 | Drug product | 2024-12-19 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD, RS | 2022-02-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD, RS | 2022-02-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD, RS | 2022-02-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD, RS | 2022-02-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD, RS | 2022-02-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD, RS | 2022-02-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD, RS | 2022-02-28 | 4b0b4de00fa7… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD, RS | 2022-02-28 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD, RS | 2022-02-28 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N216018-001 | ASPRUZYO SPRINKLE | 500MG | GRANULES, EXTENDED RELEASE / ORAL | RLD | 2022-02-28 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N216018-002 | ASPRUZYO SPRINKLE | 1GM | GRANULES, EXTENDED RELEASE / ORAL | RLD, RS | 2022-02-28 | ea1830bbd6c7… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216018-002 | 12161761 | 2038-01-24 | Drug product | 2024-12-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216018-002 | 12161761 | 2038-01-24 | Drug product | 2024-12-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216018-002 | 12161761 | 2038-01-24 | Drug product | 2024-12-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216018-002 | 12161761 | 2038-01-24 | Drug product | 2024-12-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216018-002 | 12161761 | 2038-01-24 | Drug product | 2024-12-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216018-002 | 12161761 | 2038-01-24 | Drug product | 2024-12-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216018-002 | 10898444 | 2038-01-24 | Drug product | 2022-03-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216018-002 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N216018-001 | 11510878 | 2038-01-24 | Drug product | 2022-12-01 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| ASPRUZYO SPRINKLE | RANOLAZINE | SUN PHARMACEUTICAL INDUSTRIES, INC. | dd9f81e4-50da-4551-aed5-559d304df42e | 2025-01-29 | Warnings, Adverse reactions | 216018 NDA216018 47335-624 47335-625 |