Application 019488
- Type
- NDA
- Sponsor
- CHIESI
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARDENE | NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | CARDENE | NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019488-001 | CARDENE | NICARDIPINE HYDROCHLORIDE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | |
| N019488-002 | CARDENE | NICARDIPINE HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019488-001 | CARDENE | 20MG | CAPSULE / ORAL | RLD | 1988-12-21 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019488-002 | CARDENE | 30MG | CAPSULE / ORAL | RLD | 1988-12-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019488-001 | CARDENE | 20MG | CAPSULE / ORAL | RLD | 1988-12-21 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019488-002 | CARDENE | 30MG | CAPSULE / ORAL | RLD | 1988-12-21 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | 1988-12-21 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | 1988-12-21 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Archis Pharma LLC | d0070638-bea5-413a-8658-4c752c6104f5 | 2024-12-05 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Bionpharma Inc. | 7bed5d8c-30c2-4598-acf3-2edba825a56d | 2024-11-04 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 18fb1c2b-0c1e-436c-a5b6-d4840b5da228 | 2024-08-24 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Armas Pharmaceuticals Inc. | 7226a518-164b-4755-9624-1cc75c939063 | 2024-04-04 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Epic Pharma, LLC | b8f147b8-955f-4733-9178-2cfa0beb60d6 | 2023-12-27 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | Burel Pharmaceuticals, LLC | cb902af0-b5ad-4680-b2f2-007ef2196efe | 2023-09-07 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | Eugia US LLC | 9f5d3050-9cdf-404f-ac0f-72399178959f | 2023-06-23 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | Eugia US LLC | dcd7d173-4d8e-4282-9edf-817711340e43 | 2021-10-11 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 55bd6dcc-1f12-4378-8e9e-1ceed26818f5 | 2021-07-21 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | American Regent, Inc. | 76fcb7e0-9034-4fcd-be14-ce7e9ccaee2a | 2020-05-01 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Civica, Inc. | 30fb3a4d-fa75-42fd-b4b6-2a21f202027f | 2020-05-01 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | PuraCap Laboratories LLC dba Blu Pharmaceuticals | 065efabf-8c7d-4dd5-aef2-700c2eca399d | 2019-01-07 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp | 0eb7d839-63d9-4b51-bf7b-4a8fde6339b5 | 2018-12-12 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.