Application 021632

Type: NDA
Sponsor: VICURON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERAXIS	ANIDULAFUNGIN	POWDER;INTRAVENOUS	50MG/VIAL	Yes	Yes
002	ERAXIS	ANIDULAFUNGIN	POWDER;INTRAVENOUS	100MG/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
N021632-001	ERAXIS	ANIDULAFUNGIN	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2006-02-17
N021632-002	ERAXIS	ANIDULAFUNGIN	100MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2006-11-14

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 1 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
2026-10-15 13:18:30	2026-09	N021632-001	ERAXIS	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-02-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021632-002	ERAXIS	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-11-14	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021632-001	ERAXIS	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021632-002	ERAXIS	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-11-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021632-001	ERAXIS	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021632-002	ERAXIS	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-11-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021632-001	ERAXIS	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021632-002	ERAXIS	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021632-001	ERAXIS	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021632-002	ERAXIS	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021632-001	ERAXIS	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021632-002	ERAXIS	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021632-001	ERAXIS	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021632-002	ERAXIS	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021632-001	ERAXIS	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-02-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021632-002	ERAXIS	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021632-001	ERAXIS	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-02-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021632-002	ERAXIS	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021632-001	ERAXIS	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-02-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021632-002	ERAXIS	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021632-001	ERAXIS	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-02-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021632-002	ERAXIS	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021632-001	ERAXIS	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-02-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021632-002	ERAXIS	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021632-001	ERAXIS	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-02-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021632-002	ERAXIS	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021632-001	ERAXIS	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-02-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021632-002	ERAXIS	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021632-001	ERAXIS	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-02-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021632-002	ERAXIS	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021632-001	ERAXIS	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-02-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021632-002	ERAXIS	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021632-001	ERAXIS	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-02-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021632-002	ERAXIS	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021632-001	ERAXIS	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-02-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021632-002	ERAXIS	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021632-001	ERAXIS	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-02-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021632-002	ERAXIS	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021632-001	ERAXIS	50MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-02-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021632-002	ERAXIS	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2006-11-14	`4b0b4de00fa7…`

Observed Orange Book patent history#

Patent history page 2 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-09-15 20:21 UTC	2019-09	N021632-002	6960564	2021-04-12	U-540	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021632-002	7709444	2021-04-12	U-540	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021632-001	5965525	2020-02-17	U-540	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021632-001	6960564	2021-04-12	U-540	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021632-001	7709444	2021-04-12	U-540	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021632-002	5965525	2020-02-17	U-540	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021632-002	6960564	2021-04-12	U-540	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021632-002	7709444	2021-04-12	U-540	Drug product	`ea99ee380514…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021632-001	NPP	2023-09-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021632-002	NPP	2023-09-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021632-001	NPP	2023-09-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021632-002	NPP	2023-09-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021632-001	NPP	2023-09-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021632-002	NPP	2023-09-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021632-001	NPP	2023-09-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021632-002	NPP	2023-09-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021632-001	NPP	2023-09-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021632-002	NPP	2023-09-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021632-001	NPP	2023-09-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021632-002	NPP	2023-09-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021632-001	NPP	2023-09-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021632-002	NPP	2023-09-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021632-001	NPP	2023-09-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021632-002	NPP	2023-09-22	`8869cabd3fbd…`
2023-12-20 04:57 UTC	2023-12	N021632-001	NPP	2023-09-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021632-002	NPP	2023-09-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021632-001	NPP	2023-09-22	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021632-002	NPP	2023-09-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021632-001	NPP	2023-09-22	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021632-002	NPP	2023-09-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021632-001	NPP	2023-09-22	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021632-002	NPP	2023-09-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021632-001	NPP	2023-09-22	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021632-002	NPP	2023-09-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021632-001	NPP	2023-09-22	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021632-002	NPP	2023-09-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021632-001	NPP	2023-09-22	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021632-002	NPP	2023-09-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021632-001	NPP	2023-09-22	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021632-002	NPP	2023-09-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021632-001	NPP	2023-09-22	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021632-002	NPP	2023-09-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021632-001	NPP	2023-09-22	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021632-002	NPP	2023-09-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021632-001	NPP	2023-09-22	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021632-002	NPP	2023-09-22	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ERAXIS	ANIDULAFUNGIN	Roerig	a88d9010-55fb-4a02-baff-042cd27688ea	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021632 application number: NDA021632 ndc (product): 0049-0116 ndc (product): 0049-0114
ERAXIS	ANIDULAFUNGIN	Roerig	d138ab10-1ed9-44be-8d81-49dda1e434ac	2024-02-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021632 application number: NDA021632

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0049-0114	ERAXIS	anidulafungin	Roerig	NDA	Current
0049-0114	ERAXIS	anidulafungin	Roerig	NDA	Current
0049-0114	ERAXIS	anidulafungin	Roerig	NDA	Current
0049-0114	ERAXIS	anidulafungin	Roerig	NDA	Current
0049-0116	ERAXIS	anidulafungin	Roerig	NDA	Current
0049-0116	ERAXIS	anidulafungin	Roerig	NDA	Current
0049-0116	ERAXIS	anidulafungin	Roerig	NDA	Current
0049-0116	ERAXIS	anidulafungin	Roerig	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64852	SUPPL	2020-10-06
64844	SUPPL	2020-10-06
64670	SUPPL	2020-09-24
64669	SUPPL	2020-09-24
64661	SUPPL	2020-09-23
64660	SUPPL	2020-09-23
51005	SUPPL	2018-01-09
50999	SUPPL	2018-01-09
49504	SUPPL	2017-08-22
49464	SUPPL	2017-08-18
28283	SUPPL	2012-07-24
37371	SUPPL	2012-07-23
28284	SUPPL	2010-11-09
5892	SUPPL	2009-06-16
37370	SUPPL	2009-06-10
28282	SUPPL	2007-11-19
37369	SUPPL	2007-11-13
37368	SUPPL	2007-02-21
5891	SUPPL	2007-02-12
28281	SUPPL	2006-11-22
15903	SUPPL	2006-11-16
15902	SUPPL	2006-08-09
5890	SUPPL	2006-08-09
21763	ORIG	2006-04-14
28280	ORIG	2006-03-01
15901	ORIG	2006-02-28