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| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |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| NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |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| CARDENE | NICARDIPINE HYDROCHLORIDE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | |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| CARDENE | NICARDIPINE HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 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UTC | 2019-12 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | 1988-12-21 | 74a2ff9319b5… | ||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UTC | 2019-12 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | 1988-12-21 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | 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 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | RLD | 1988-12-21 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | 1988-12-21 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | 1988-12-21 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | 1988-12-21 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | 1988-12-21 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | 1988-12-21 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | 1988-12-21 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | 1988-12-21 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | 1988-12-21 | c0c555d07b60… | ||
| 2019-12-14 00:12 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 | 3f01610625f2… | ||
| 2019-12-14 00:12 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 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | 1988-12-21 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | 1988-12-21 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N019488-001 | CARDENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | 1988-12-21 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N019488-002 | CARDENE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | 1988-12-21 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | 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 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | 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 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | 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 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | 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 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | 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 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | 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 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | 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 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | 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 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | 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 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | 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 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | 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 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | 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 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | 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 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | 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 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | 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 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | 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 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | 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 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | 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 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | 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 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | 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 | 3a93d1ddd44b… |
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 | Meitheal Pharmaceuticals Inc. | 372a4381-7302-4df7-81bb-a9521907f867 | 2026-08-10 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | Micro Labs Limited | 8e8611e0-7d8c-4f30-b53a-76c6588b6ef7 | 2026-08-04 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | Amerisyn LLC | 575c5dab-e832-192a-e063-6294a90a34a1 | 2026-07-24 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Caplin Steriles Limited | 9383f1dc-0310-4c87-a8f0-48c09a85d89b | 2026-06-25 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine hydrochloride | NICARDIPINE HYDROCHLORIDE | Lifestar Pharma LLC | b0e2bed3-f928-43ab-a05c-275bedc9856f | 2026-04-24 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Somerset Therapeutics, LLC | f8b49f59-7a54-425d-9eca-dfa4022a08d1 | 2026-04-20 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| CARDENE IV | NICARDIPINE HYDROCHLORIDE | Baxter Healthcare Corporation | a3e33add-0d09-423a-9109-42e5ba7148d5 | 2026-04-13 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Cardene IV | NICARDIPINE HYDROCHLORIDE | Baxter Healthcare Corporation | 5499cfac-9147-4d5d-a8cb-f8d64f1481af | 2026-04-13 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| CARDENE IV | NICARDIPINE HYDROCHLORIDE | Baxter Healthcare Corporation | f12cea0d-b7cd-41d8-b551-2c74cc7f5f4e | 2026-03-27 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | cdafe6cc-b03e-4e72-9d0a-6baa977149d6 | 2026-03-06 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Glenmark Pharmaceuticals Inc., USA | 3955d43d-a87f-4d2c-b90e-3ecf0d6aa148 | 2026-01-29 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | Amici Pharma Inc | edda985c-004e-4487-b856-13cf2cdb900f | 2026-01-08 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| CARDENE IV | NICARDIPINE HYDROCHLORIDE | Baxter Healthcare Corporation | 5749599d-ff2a-42e4-aa72-cd25013feee8 | 2025-12-29 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Sagent Pharmaceuticals | c576c9d5-853b-4e93-be6c-3579dfa5564c | 2025-12-29 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | d1e275b8-c71a-4e8b-bca0-cfea048b5343 | 2025-12-22 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | Chengdu Shuode Pharmaceutical Co., Ltd | 433dbca3-0a86-44c2-835d-1051c1c93878 | 2025-11-10 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Qilu Pharmaceutical Co., Ltd. | 7433b5cd-9c3a-428a-bcaf-00f02cd52633 | 2025-04-23 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | Cipla USA Inc. | 570af1f8-6718-4b40-ae89-0f738d330ebd | 2025-04-08 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 9d898911-d811-2a78-e053-2995a90af784 | 2025-01-08 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Archis Pharma LLC | d0070638-bea5-413a-8658-4c752c6104f5 | 2024-12-05 | Warnings, Adverse reactions | NICARDIPINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.