Application 217415
- Type
- NDA
- Sponsor
- XELLIA PHARMS APS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DAPTOMYCIN | DAPTOMYCIN | POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER | 350MG | No | No |
| 002 | DAPTOMYCIN | DAPTOMYCIN | POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER | 500MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N217415-001 | DAPTOMYCIN | DAPTOMYCIN | 350MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2023-01-30 | |
| N217415-002 | DAPTOMYCIN | DAPTOMYCIN | 500MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2023-01-30 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N217415-001 | 11759497 | 2038-08-28 | Drug product | 2023-10-12 | |
| N217415-001 | 12053502 | 2038-08-28 | U-3981 | 2024-09-04 | |
| N217415-001 | 12629337 | 2043-01-09 | Drug product | 2026-06-10 | |
| N217415-002 | 11759497 | 2038-08-28 | Drug product | 2023-10-12 | |
| N217415-002 | 12053502 | 2038-08-28 | U-3981 | 2024-09-04 | |
| N217415-002 | 12629337 | 2043-01-09 | Drug product | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N217415-001 | DAPTOMYCIN | 350MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2023-01-30 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N217415-002 | DAPTOMYCIN | 500MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2023-01-30 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N217415-001 | DAPTOMYCIN | 350MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2023-01-30 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N217415-002 | DAPTOMYCIN | 500MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2023-01-30 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N217415-001 | DAPTOMYCIN | 350MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2023-01-30 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N217415-002 | DAPTOMYCIN | 500MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2023-01-30 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N217415-001 | DAPTOMYCIN | 350MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2023-01-30 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N217415-002 | DAPTOMYCIN | 500MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2023-01-30 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N217415-001 | DAPTOMYCIN | 350MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2023-01-30 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N217415-002 | DAPTOMYCIN | 500MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2023-01-30 | 053a50430f4f… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217415-001 | DAPTOMYCIN | 350MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2023-01-30 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217415-002 | DAPTOMYCIN | 500MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2023-01-30 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N217415-001 | 11759497 | 2038-08-28 | Drug product | 2023-10-12 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N217415-001 | 12053502 | 2038-08-28 | U-3981 | 2024-09-04 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N217415-001 | 12629337 | 2043-01-09 | Drug product | 2026-06-10 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N217415-002 | 11759497 | 2038-08-28 | Drug product | 2023-10-12 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N217415-002 | 12053502 | 2038-08-28 | U-3981 | 2024-09-04 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N217415-002 | 12629337 | 2043-01-09 | Drug product | 2026-06-10 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N217415-001 | 11759497 | 2038-08-28 | Drug product | 2023-10-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N217415-001 | 12053502 | 2038-08-28 | U-3981 | 2024-09-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N217415-001 | 12629337 | 2043-01-09 | Drug product | 2026-06-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N217415-002 | 11759497 | 2038-08-28 | Drug product | 2023-10-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N217415-002 | 12053502 | 2038-08-28 | U-3981 | 2024-09-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N217415-002 | 12629337 | 2043-01-09 | Drug product | 2026-06-10 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N217415-001 | 11759497 | 2038-08-28 | Drug product | 2023-10-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N217415-001 | 12053502 | 2038-08-28 | U-3981 | 2024-09-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N217415-001 | 12629337 | 2043-01-09 | Drug product | 2026-06-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N217415-002 | 11759497 | 2038-08-28 | Drug product | 2023-10-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N217415-002 | 12053502 | 2038-08-28 | U-3981 | 2024-09-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N217415-002 | 12629337 | 2043-01-09 | Drug product | 2026-06-10 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217415-001 | 11759497 | 2038-08-28 | Drug product | 2023-10-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217415-001 | 12053502 | 2038-08-28 | U-3981 | 2024-09-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217415-002 | 11759497 | 2038-08-28 | Drug product | 2023-10-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217415-002 | 12053502 | 2038-08-28 | U-3981 | 2024-09-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217415-001 | 11759497 | 2038-08-28 | Drug product | 2023-10-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217415-001 | 12053502 | 2038-08-28 | U-3981 | 2024-09-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217415-002 | 11759497 | 2038-08-28 | Drug product | 2023-10-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217415-002 | 12053502 | 2038-08-28 | U-3981 | 2024-09-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217415-001 | 11759497 | 2038-08-28 | Drug product | 2023-10-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217415-001 | 12053502 | 2038-08-28 | U-3981 | 2024-09-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217415-002 | 11759497 | 2038-08-28 | Drug product | 2023-10-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217415-002 | 12053502 | 2038-08-28 | U-3981 | 2024-09-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N217415-001 | 11759497 | 2038-08-28 | Drug product | 2023-10-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N217415-001 | 12053502 | 2038-08-28 | U-3981 | 2024-09-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N217415-002 | 11759497 | 2038-08-28 | Drug product | 2023-10-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N217415-002 | 12053502 | 2038-08-28 | U-3981 | 2024-09-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N217415-001 | 11759497 | 2038-08-28 | Drug product | 2023-10-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N217415-001 | 12053502 | 2038-08-28 | U-3981 | 2024-09-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N217415-002 | 11759497 | 2038-08-28 | Drug product | 2023-10-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N217415-002 | 12053502 | 2038-08-28 | U-3981 | 2024-09-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N217415-001 | 11759497 | 2038-08-28 | Drug product | 2023-10-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N217415-001 | 12053502 | 2038-08-28 | U-3981 | 2024-09-04 | 03ed91905a0d… |
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 |
|---|---|---|---|---|---|---|
| Daptomycin | DAPTOMYCIN | Civica, Inc. | 1ae55ae0-d20f-4e15-b4dc-7e45c33f3152 | 2026-04-09 | Warnings, Adverse reactions | 217415 NDA217415 |
| Daptomycin | DAPTOMYCIN | Hikma Pharmaceuticals USA Inc. | 74176769-b22e-4e41-8c56-051e15ec5fea | 2025-12-18 | Warnings, Adverse reactions | 217415 NDA217415 |
| Daptomycin | DAPTOMYCIN | Xellia Pharmaceuticals USA LLC | 5e1f739a-eb81-43d8-9a14-89f32b7e1ba1 | 2024-05-24 | Warnings, Adverse reactions | 217415 NDA217415 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.