Application 022156
- Type
- NDA
- Sponsor
- CHIESI
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | 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#
| Application-product | Patent | Expiration | Use code | 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N022156-001 | CLEVIPREX | 25MG/50ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022156-002 | CLEVIPREX | 50MG/100ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022156-003 | CLEVIPREX | 125MG/250ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD | 2013-11-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022156-001 | CLEVIPREX | 25MG/50ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022156-002 | CLEVIPREX | 50MG/100ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022156-003 | CLEVIPREX | 125MG/250ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD | 2013-11-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022156-001 | CLEVIPREX | 25MG/50ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022156-002 | CLEVIPREX | 50MG/100ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022156-003 | CLEVIPREX | 125MG/250ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD | 2013-11-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022156-001 | CLEVIPREX | 25MG/50ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022156-002 | CLEVIPREX | 50MG/100ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022156-003 | CLEVIPREX | 125MG/250ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD | 2013-11-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022156-001 | CLEVIPREX | 25MG/50ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022156-002 | CLEVIPREX | 50MG/100ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022156-003 | CLEVIPREX | 125MG/250ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD | 2013-11-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022156-001 | CLEVIPREX | 25MG/50ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022156-002 | CLEVIPREX | 50MG/100ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022156-003 | CLEVIPREX | 125MG/250ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD | 2013-11-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022156-001 | CLEVIPREX | 25MG/50ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022156-002 | CLEVIPREX | 50MG/100ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022156-003 | CLEVIPREX | 125MG/250ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD | 2013-11-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022156-001 | CLEVIPREX | 25MG/50ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022156-002 | CLEVIPREX | 50MG/100ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022156-003 | CLEVIPREX | 125MG/250ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD | 2013-11-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022156-001 | CLEVIPREX | 25MG/50ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022156-002 | CLEVIPREX | 50MG/100ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022156-003 | CLEVIPREX | 125MG/250ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD | 2013-11-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022156-001 | CLEVIPREX | 25MG/50ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022156-002 | CLEVIPREX | 50MG/100ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022156-003 | CLEVIPREX | 125MG/250ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD | 2013-11-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022156-001 | CLEVIPREX | 25MG/50ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022156-002 | CLEVIPREX | 50MG/100ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022156-003 | CLEVIPREX | 125MG/250ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD | 2013-11-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022156-001 | CLEVIPREX | 25MG/50ML (0.5MG/ML) | EMULSION / INTRAVENOUS | RLD, RS | 2008-08-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022156-002 | 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… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 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… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022156-002 | 11103490 | 2031-10-10 | Drug product | 2021-09-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022156-002 | 8658676 | 2031-10-10 | Drug product | 2014-03-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022156-003 | 10010537 | 2031-10-10 | Drug product | 2018-07-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022156-003 | 11103490 | 2031-10-10 | Drug product | 2021-09-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022156-003 | 8658676 | 2031-10-10 | Drug product | 2014-03-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022156-001 | 10010537 | 2031-10-10 | Drug product | 2018-07-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022156-001 | 11103490 | 2031-10-10 | Drug product | 2021-09-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022156-001 | 8658676 | 2031-10-10 | Drug product | 2014-03-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022156-002 | 10010537 | 2031-10-10 | Drug product | 2018-07-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022156-002 | 11103490 | 2031-10-10 | Drug product | 2021-09-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022156-002 | 8658676 | 2031-10-10 | Drug product | 2014-03-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022156-003 | 10010537 | 2031-10-10 | Drug product | 2018-07-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022156-003 | 11103490 | 2031-10-10 | Drug product | 2021-09-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022156-003 | 8658676 | 2031-10-10 | Drug product | 2014-03-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022156-001 | 10010537 | 2031-10-10 | Drug product | 2018-07-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022156-001 | 11103490 | 2031-10-10 | Drug product | 2021-09-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022156-001 | 8658676 | 2031-10-10 | Drug product | 2014-03-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022156-002 | 10010537 | 2031-10-10 | Drug product | 2018-07-12 | fd3edfee7708… |
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 |
|---|---|---|---|---|---|---|
| Cleviprex | CLEVIPIDINE | Chiesi USA, Inc. | f9290625-b723-4eda-bab8-a97bef6041f6 | 2025-11-06 | Warnings, Adverse reactions | 022156 NDA022156 10122-610 10122-611 |
| Cleviprex | CLEVIDIPINE | Fresenius Kabi Austria GmbH | a6826aa3-fabb-4ff1-a7a3-cd4c34e3a330 | 2022-11-09 | Warnings, Adverse reactions | 022156 NDA022156 18124-011 |
NDC Listings For This Application#
| 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 |