Application 020491

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CORVERT	IBUTILIDE FUMARATE	INJECTABLE;INJECTION	0.1MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020491-001	CORVERT	IBUTILIDE FUMARATE	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020491-001	AP

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020491-001	CORVERT	0.1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1995-12-28	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N020491-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020491-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020491-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020491-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020491-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020491-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020491-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020491-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020491-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020491-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020491-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020491-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020491-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020491-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020491-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020491-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020491-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020491-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020491-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020491-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020491-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020491-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020491-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020491-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020491-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020491-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020491-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020491-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020491-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020491-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020491-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020491-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020491-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020491-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020491-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020491-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020491-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020491-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020491-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020491-001	AP	1	`f41ea6bd6efb…`

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
Corvert	IBUTILIDE FUMARATE	Pharmacia & Upjohn Company LLC	2428969a-7431-4e94-9503-ad5c680e2ea4	2024-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020491 application number: NDA020491 ndc (product): 0009-3794
Corvert	IBUTILIDE FUMARATE	Pharmacia & Upjohn Company LLC	b7d717ed-022d-4459-b5e6-098c2a8b7427	2024-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020491 application number: NDA020491 ndc (product): 0009-3794

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-3794	Corvert	ibutilide fumarate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-3794	Corvert	ibutilide fumarate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3794	Corvert	ibutilide fumarate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3794	Corvert	ibutilide fumarate	Pharmacia and Upjohn Company LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
20682	SUPPL	2001-04-20
12634	SUPPL	2001-04-20
2599	SUPPL	2001-04-20
34708	SUPPL	1999-05-13
20680	SUPPL	1999-05-13
2598	SUPPL	1999-05-13
20681	SUPPL	1998-04-03
57463	ORIG	1996-03-16