Application 022065

Type: NDA
Sponsor: R-PHARM US LLC

Application Products#

Product, Drug, Ingredient table
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
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.

Product history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022065-001	IXEMPRA KIT	15MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022065-002	IXEMPRA KIT	45MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022065-001	IXEMPRA KIT	15MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022065-002	IXEMPRA KIT	45MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022065-001	IXEMPRA KIT	15MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022065-002	IXEMPRA KIT	45MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022065-001	IXEMPRA KIT	15MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022065-002	IXEMPRA KIT	45MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022065-001	IXEMPRA KIT	15MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022065-002	IXEMPRA KIT	45MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022065-001	IXEMPRA KIT	15MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022065-002	IXEMPRA KIT	45MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022065-001	IXEMPRA KIT	15MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022065-002	IXEMPRA KIT	45MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022065-001	IXEMPRA KIT	15MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022065-002	IXEMPRA KIT	45MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022065-001	IXEMPRA KIT	15MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022065-002	IXEMPRA KIT	45MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022065-001	IXEMPRA KIT	15MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022065-002	IXEMPRA KIT	45MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022065-001	IXEMPRA KIT	15MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022065-002	IXEMPRA KIT	45MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022065-001	IXEMPRA KIT	15MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N022065-002	IXEMPRA KIT	45MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022065-001	IXEMPRA KIT	15MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N022065-002	IXEMPRA KIT	45MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022065-001	IXEMPRA KIT	15MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022065-002	IXEMPRA KIT	45MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022065-001	IXEMPRA KIT	15MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022065-002	IXEMPRA KIT	45MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022065-001	IXEMPRA KIT	15MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022065-002	IXEMPRA KIT	45MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022065-001	IXEMPRA KIT	15MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022065-002	IXEMPRA KIT	45MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022065-001	IXEMPRA KIT	15MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N022065-002	IXEMPRA KIT	45MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022065-001	IXEMPRA KIT	15MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N022065-002	IXEMPRA KIT	45MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022065-001	IXEMPRA KIT	15MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022065-002	IXEMPRA KIT	45MG/VIAL	INJECTABLE / INTRAVENOUS	RLD, RS	2007-10-16	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 432 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022065-001	7312237	2024-08-21	U-965		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022065-001	7312237*PED	2025-02-21		Pediatric extension	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022065-002	7312237	2024-08-21	U-965		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022065-002	7312237*PED	2025-02-21		Pediatric extension	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022065-001	7312237*PED	2025-02-21		Pediatric extension	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022065-002	7312237*PED	2025-02-21		Pediatric extension	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022065-001	7312237*PED	2025-02-21		Pediatric extension	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022065-002	7312237*PED	2025-02-21		Pediatric extension	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022065-001	7312237*PED	2025-02-21		Pediatric extension	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022065-002	7312237*PED	2025-02-21		Pediatric extension	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022065-001	7312237	2024-08-21	U-965		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022065-001	7312237*PED	2025-02-21		Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022065-002	7312237	2024-08-21	U-965		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022065-002	7312237*PED	2025-02-21		Pediatric extension	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022065-001	7312237	2024-08-21	U-965		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022065-001	7312237*PED	2025-02-21		Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022065-002	7312237	2024-08-21	U-965		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022065-002	7312237*PED	2025-02-21		Pediatric extension	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022065-001	7312237	2024-08-21	U-965		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022065-001	7312237*PED	2025-02-21		Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022065-002	7312237	2024-08-21	U-965		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022065-002	7312237*PED	2025-02-21		Pediatric extension	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022065-001	7312237	2024-08-21	U-965		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022065-001	7312237*PED	2025-02-21		Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022065-002	7312237	2024-08-21	U-965		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022065-002	7312237*PED	2025-02-21		Pediatric extension	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022065-001	7312237	2024-08-21	U-965		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022065-001	7312237*PED	2025-02-21		Pediatric extension	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022065-002	7312237	2024-08-21	U-965		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022065-002	7312237*PED	2025-02-21		Pediatric extension	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022065-001	7312237	2024-08-21	U-965		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022065-001	7312237*PED	2025-02-21		Pediatric extension	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022065-002	7312237	2024-08-21	U-965		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022065-002	7312237*PED	2025-02-21		Pediatric extension	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022065-001	7312237	2024-08-21	U-965		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022065-001	7312237*PED	2025-02-21		Pediatric extension	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022065-002	7312237	2024-08-21	U-965		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022065-002	7312237*PED	2025-02-21		Pediatric extension	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022065-001	7312237	2024-08-21	U-965		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022065-001	7312237*PED	2025-02-21		Pediatric extension	`1e350fbaab3a…`

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (NDA): 022065 application number: NDA022065 ndc (product): 70020-1910 ndc (product): 70020-1911

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
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 table
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