Application 022065
- Type
- NDA
- Sponsor
- R-PHARM US LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IXEMPRA KIT | IXABEPILONE | INJECTABLE;INTRAVENOUS | 15MG/VIAL | Yes | Yes |
| 002 | IXEMPRA KIT | IXABEPILONE | INJECTABLE;INTRAVENOUS | 45MG/VIAL | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022065-001 | IXEMPRA KIT | IXABEPILONE | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | |
| N022065-002 | IXEMPRA KIT | IXABEPILONE | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N022065-001 | IXEMPRA KIT | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N022065-002 | IXEMPRA KIT | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N022065-001 | IXEMPRA KIT | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022065-002 | IXEMPRA KIT | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022065-001 | IXEMPRA KIT | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022065-002 | IXEMPRA KIT | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022065-001 | IXEMPRA KIT | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022065-002 | IXEMPRA KIT | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022065-001 | IXEMPRA KIT | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022065-002 | IXEMPRA KIT | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022065-001 | IXEMPRA KIT | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022065-002 | IXEMPRA KIT | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022065-001 | IXEMPRA KIT | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022065-002 | IXEMPRA KIT | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022065-001 | IXEMPRA KIT | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022065-002 | IXEMPRA KIT | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022065-001 | IXEMPRA KIT | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022065-002 | IXEMPRA KIT | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022065-001 | IXEMPRA KIT | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022065-002 | IXEMPRA KIT | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022065-001 | IXEMPRA KIT | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022065-002 | IXEMPRA KIT | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022065-001 | IXEMPRA KIT | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022065-002 | IXEMPRA KIT | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022065-001 | IXEMPRA KIT | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022065-002 | IXEMPRA KIT | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022065-001 | IXEMPRA KIT | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022065-002 | IXEMPRA KIT | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022065-001 | IXEMPRA KIT | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022065-002 | IXEMPRA KIT | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022065-001 | IXEMPRA KIT | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022065-002 | IXEMPRA KIT | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022065-001 | IXEMPRA KIT | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022065-002 | IXEMPRA KIT | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022065-001 | IXEMPRA KIT | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022065-002 | IXEMPRA KIT | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022065-001 | IXEMPRA KIT | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022065-002 | IXEMPRA KIT | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022065-001 | IXEMPRA KIT | 15MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022065-002 | IXEMPRA KIT | 45MG/VIAL | INJECTABLE / INTRAVENOUS | RLD, RS | 2007-10-16 | 4b0b4de00fa7… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022065-002 | 7312237 | 2024-08-21 | U-965 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022065-002 | 7312237*PED | 2025-02-21 | Pediatric extension | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N022065-001 | 7312237 | 2024-08-21 | U-965 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N022065-001 | 7312237*PED | 2025-02-21 | Pediatric extension | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N022065-002 | 7312237 | 2024-08-21 | U-965 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N022065-002 | 7312237*PED | 2025-02-21 | Pediatric extension | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022065-001 | 6670384 | 2022-01-23 | U-960 | Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022065-001 | 6670384 | 2022-01-23 | U-959 | Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022065-001 | 7022330 | 2022-01-23 | U-958 | Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022065-001 | RE41393 | 2022-02-08 | U-961 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022065-001 | 6670384*PED | 2022-07-23 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022065-001 | 7022330*PED | 2022-07-23 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022065-001 | RE41393*PED | 2022-08-08 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022065-001 | 7312237 | 2024-08-21 | U-965 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022065-001 | 7312237*PED | 2025-02-21 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022065-002 | 6670384 | 2022-01-23 | U-959 | Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022065-002 | 6670384 | 2022-01-23 | U-960 | Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022065-002 | 7022330 | 2022-01-23 | U-958 | Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022065-002 | RE41393 | 2022-02-08 | U-961 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022065-002 | 6670384*PED | 2022-07-23 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022065-002 | 7022330*PED | 2022-07-23 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022065-002 | RE41393*PED | 2022-08-08 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022065-002 | 7312237 | 2024-08-21 | U-965 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022065-002 | 7312237*PED | 2025-02-21 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022065-001 | 6670384 | 2022-01-23 | U-960 | Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022065-001 | 6670384 | 2022-01-23 | U-959 | Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022065-001 | 7022330 | 2022-01-23 | U-958 | Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022065-001 | RE41393 | 2022-02-08 | U-961 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022065-001 | 6670384*PED | 2022-07-23 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022065-001 | 7022330*PED | 2022-07-23 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022065-001 | RE41393*PED | 2022-08-08 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022065-001 | 7312237 | 2024-08-21 | U-965 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022065-001 | 7312237*PED | 2025-02-21 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022065-002 | 6670384 | 2022-01-23 | U-959 | Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022065-002 | 6670384 | 2022-01-23 | U-960 | Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022065-002 | 7022330 | 2022-01-23 | U-958 | Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022065-002 | RE41393 | 2022-02-08 | U-961 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022065-002 | 6670384*PED | 2022-07-23 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022065-002 | 7022330*PED | 2022-07-23 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022065-002 | RE41393*PED | 2022-08-08 | Pediatric extension | 5d02ea3f76ae… |
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 |
|---|---|---|---|---|---|---|
| IXEMPRA | IXABEPILONE | R-Pharm US Operating, LLC | 241f0b1e-8b95-470d-876f-bf1804daaf18 | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | 022065 NDA022065 70020-1910 70020-1911 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70020-1910 | IXEMPRA | ixabepilone | R-Pharm US Operating, LLC | NDA | Current |
| 70020-1910 | IXEMPRA | ixabepilone | R-Pharm US Operating, LLC | NDA | Current |
| 70020-1910 | IXEMPRA | ixabepilone | R-Pharm US Operating, LLC | NDA | Current |
| 70020-1910 | IXEMPRA | ixabepilone | R-Pharm US Operating, LLC | NDA | Current |
| 70020-1910 | IXEMPRA | ixabepilone | R-Pharm US Operating, LLC | NDA | Current |
| 70020-1910 | IXEMPRA | ixabepilone | R-Pharm US Operating, LLC | NDA | Current |
| 70020-1910 | IXEMPRA | ixabepilone | R-Pharm US Operating, LLC | NDA | Current |
| 70020-1911 | IXEMPRA | ixabepilone | R-Pharm US Operating, LLC | NDA | Current |
| 70020-1911 | IXEMPRA | ixabepilone | R-Pharm US Operating, LLC | NDA | Current |
| 70020-1911 | IXEMPRA | ixabepilone | R-Pharm US Operating, LLC | NDA | Current |
| 70020-1911 | IXEMPRA | ixabepilone | R-Pharm US Operating, LLC | NDA | Current |
| 70020-1911 | IXEMPRA | ixabepilone | R-Pharm US Operating, LLC | NDA | Current |
| 70020-1911 | IXEMPRA | ixabepilone | R-Pharm US Operating, LLC | NDA | Current |
| 70020-1911 | IXEMPRA | ixabepilone | R-Pharm US Operating, LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 73147 | SUPPL | 2023-01-13 |
| 73144 | SUPPL | 2023-01-12 |
| 69967 | SUPPL | 2022-01-25 |
| 69956 | SUPPL | 2022-01-25 |
| 38177 | SUPPL | 2011-10-20 |
| 6805 | SUPPL | 2011-10-20 |
| 52939 | SUPPL | 2011-04-05 |
| 52938 | SUPPL | 2011-04-05 |
| 52937 | SUPPL | 2011-04-05 |
| 51943 | SUPPL | 2011-04-05 |
| 51942 | SUPPL | 2011-04-05 |
| 51941 | SUPPL | 2011-04-05 |
| 38176 | SUPPL | 2010-05-17 |
| 38175 | SUPPL | 2010-05-17 |
| 29186 | SUPPL | 2010-05-17 |
| 6804 | SUPPL | 2010-05-17 |
| 29185 | SUPPL | 2009-10-13 |
| 6803 | SUPPL | 2009-10-13 |
| 16875 | SUPPL | 2009-10-07 |
| 16874 | SUPPL | 2009-10-07 |
| 38174 | SUPPL | 2009-04-03 |
| 6802 | SUPPL | 2009-03-17 |
| 42406 | ORIG | 2008-03-24 |
| 29184 | ORIG | 2007-10-22 |
| 16873 | ORIG | 2007-10-17 |
| 64238 | SUPPL | 1900-01-01 |