Application 022156

Type: NDA
Sponsor: CHIESI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLEVIPREX	CLEVIDIPINE	EMULSION;INTRAVENOUS	25MG/50ML (0.5MG/ML)	Yes	Yes
002	CLEVIPREX	CLEVIDIPINE	EMULSION;INTRAVENOUS	50MG/100ML (0.5MG/ML)	Yes	Yes
003	CLEVIPREX	CLEVIDIPINE	EMULSION;INTRAVENOUS	125MG/250ML (0.5MG/ML)	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022156-001	CLEVIPREX	CLEVIDIPINE	25MG/50ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01
N022156-002	CLEVIPREX	CLEVIDIPINE	50MG/100ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01
N022156-003	CLEVIPREX	CLEVIDIPINE	125MG/250ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD	2013-11-08

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N022156-001	10010537	2031-10-10	Drug product	2018-07-12
N022156-001	11103490	2031-10-10	Drug product	2021-09-01
N022156-001	8658676	2031-10-10	Drug product	2014-03-06
N022156-002	10010537	2031-10-10	Drug product	2018-07-12
N022156-002	11103490	2031-10-10	Drug product	2021-09-01
N022156-002	8658676	2031-10-10	Drug product	2014-03-06
N022156-003	10010537	2031-10-10	Drug product	2018-07-12
N022156-003	11103490	2031-10-10	Drug product	2021-09-01
N022156-003	8658676	2031-10-10	Drug product	2014-03-06

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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022156-002	CLEVIPREX	50MG/100ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022156-003	CLEVIPREX	125MG/250ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD	2013-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022156-001	CLEVIPREX	25MG/50ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022156-002	CLEVIPREX	50MG/100ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022156-003	CLEVIPREX	125MG/250ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD	2013-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022156-001	CLEVIPREX	25MG/50ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022156-002	CLEVIPREX	50MG/100ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022156-003	CLEVIPREX	125MG/250ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD	2013-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022156-001	CLEVIPREX	25MG/50ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022156-002	CLEVIPREX	50MG/100ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022156-003	CLEVIPREX	125MG/250ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD	2013-11-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022156-001	CLEVIPREX	25MG/50ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022156-002	CLEVIPREX	50MG/100ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022156-003	CLEVIPREX	125MG/250ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD	2013-11-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022156-001	CLEVIPREX	25MG/50ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022156-002	CLEVIPREX	50MG/100ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022156-003	CLEVIPREX	125MG/250ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD	2013-11-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022156-001	CLEVIPREX	25MG/50ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022156-002	CLEVIPREX	50MG/100ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022156-003	CLEVIPREX	125MG/250ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD	2013-11-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022156-001	CLEVIPREX	25MG/50ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022156-002	CLEVIPREX	50MG/100ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022156-003	CLEVIPREX	125MG/250ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD	2013-11-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022156-001	CLEVIPREX	25MG/50ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022156-002	CLEVIPREX	50MG/100ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022156-003	CLEVIPREX	125MG/250ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD	2013-11-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022156-001	CLEVIPREX	25MG/50ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022156-002	CLEVIPREX	50MG/100ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022156-003	CLEVIPREX	125MG/250ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD	2013-11-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022156-001	CLEVIPREX	25MG/50ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022156-002	CLEVIPREX	50MG/100ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022156-003	CLEVIPREX	125MG/250ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD	2013-11-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022156-001	CLEVIPREX	25MG/50ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022156-002	CLEVIPREX	50MG/100ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022156-003	CLEVIPREX	125MG/250ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD	2013-11-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022156-001	CLEVIPREX	25MG/50ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022156-002	CLEVIPREX	50MG/100ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022156-003	CLEVIPREX	125MG/250ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD	2013-11-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022156-001	CLEVIPREX	25MG/50ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022156-002	CLEVIPREX	50MG/100ML (0.5MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2008-08-01	`c0c555d07b60…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 399 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022156-001	10010537	2031-10-10	Drug product	2018-07-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022156-001	11103490	2031-10-10	Drug product	2021-09-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022156-001	8658676	2031-10-10	Drug product	2014-03-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022156-002	10010537	2031-10-10	Drug product	2018-07-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022156-002	11103490	2031-10-10	Drug product	2021-09-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022156-002	8658676	2031-10-10	Drug product	2014-03-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022156-003	10010537	2031-10-10	Drug product	2018-07-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022156-003	11103490	2031-10-10	Drug product	2021-09-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022156-003	8658676	2031-10-10	Drug product	2014-03-06	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022156-001	10010537	2031-10-10	Drug product	2018-07-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022156-001	11103490	2031-10-10	Drug product	2021-09-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022156-001	8658676	2031-10-10	Drug product	2014-03-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022156-002	10010537	2031-10-10	Drug product	2018-07-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022156-002	11103490	2031-10-10	Drug product	2021-09-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022156-002	8658676	2031-10-10	Drug product	2014-03-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022156-003	10010537	2031-10-10	Drug product	2018-07-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022156-003	11103490	2031-10-10	Drug product	2021-09-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022156-003	8658676	2031-10-10	Drug product	2014-03-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022156-001	10010537	2031-10-10	Drug product	2018-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022156-001	11103490	2031-10-10	Drug product	2021-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022156-001	8658676	2031-10-10	Drug product	2014-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022156-002	10010537	2031-10-10	Drug product	2018-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022156-002	11103490	2031-10-10	Drug product	2021-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022156-002	8658676	2031-10-10	Drug product	2014-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022156-003	10010537	2031-10-10	Drug product	2018-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022156-003	11103490	2031-10-10	Drug product	2021-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022156-003	8658676	2031-10-10	Drug product	2014-03-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022156-001	10010537	2031-10-10	Drug product	2018-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022156-001	11103490	2031-10-10	Drug product	2021-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022156-001	8658676	2031-10-10	Drug product	2014-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022156-002	10010537	2031-10-10	Drug product	2018-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022156-002	11103490	2031-10-10	Drug product	2021-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022156-002	8658676	2031-10-10	Drug product	2014-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022156-003	10010537	2031-10-10	Drug product	2018-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022156-003	11103490	2031-10-10	Drug product	2021-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022156-003	8658676	2031-10-10	Drug product	2014-03-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022156-001	10010537	2031-10-10	Drug product	2018-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022156-001	11103490	2031-10-10	Drug product	2021-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022156-001	8658676	2031-10-10	Drug product	2014-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022156-002	10010537	2031-10-10	Drug product	2018-07-12	`31067a03dcf5…`

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
Cleviprex	CLEVIPIDINE	Chiesi USA, Inc.	f9290625-b723-4eda-bab8-a97bef6041f6	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022156 application number: NDA022156 ndc (product): 10122-610 ndc (product): 10122-611
Cleviprex	CLEVIDIPINE	Fresenius Kabi Austria GmbH	a6826aa3-fabb-4ff1-a7a3-cd4c34e3a330	2022-11-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022156 application number: NDA022156 ndc (product): 18124-011

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10122-610	Cleviprex	clevipidine	Chiesi USA, Inc.	NDA	Current
10122-610	Cleviprex	clevipidine	Chiesi USA, Inc.	NDA	Current
10122-610	Cleviprex	clevipidine	Chiesi USA, Inc.	NDA	Current
10122-610	Cleviprex	clevipidine	Chiesi USA, Inc.	NDA	Current
10122-610	Cleviprex	clevipidine	Chiesi USA, Inc.	NDA	Current
10122-610	Cleviprex	clevipidine	Chiesi USA, Inc.	NDA	Current
10122-611	Cleviprex	clevipidine	Chiesi USA, Inc.	NDA	Current
10122-611	Cleviprex	clevipidine	Chiesi USA, Inc.	NDA	Current
10122-611	Cleviprex	clevipidine	Chiesi USA, Inc.	NDA	Current
10122-611	Cleviprex	clevipidine	Chiesi USA, Inc.	NDA	Current
10122-611	Cleviprex	clevipidine	Chiesi USA, Inc.	NDA	Current
10122-611	Cleviprex	clevipidine	Chiesi USA, Inc.	NDA	Current
10122-612	Cleviprex	clevipidine	Chiesi USA, Inc.	NDA	Current
10122-612	Cleviprex	clevipidine	Chiesi USA, Inc.	NDA	Current
18124-011	Cleviprex	clevidipine	Fresenius Kabi Austria GmbH	NDA	Current
18124-011	Cleviprex	clevidipine	Fresenius Kabi Austria GmbH	NDA	Current
18124-011	Cleviprex	clevidipine	Fresenius Kabi Austria GmbH	NDA	Current
65293-005	Cleviprex	clevidipine	The Medicines Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67109	SUPPL	2021-04-19
67101	SUPPL	2021-04-19
29334	SUPPL	2011-12-14
38316	SUPPL	2011-12-13
44686	ORIG	2008-09-23
21948	ORIG	2008-09-23
29333	ORIG	2008-08-08