FDA.reportPublic FDA data

Application 019488

Type
NDA
Sponsor
CHIESI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARDENENICARDIPINE HYDROCHLORIDECAPSULE;ORAL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
002CARDENENICARDIPINE HYDROCHLORIDECAPSULE;ORAL30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019488-001CARDENENICARDIPINE HYDROCHLORIDE20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1988-12-21
N019488-002CARDENENICARDIPINE HYDROCHLORIDE30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1988-12-21

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.

Product history page 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N019488-001CARDENE20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1988-12-21f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N019488-002CARDENE30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1988-12-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019488-001CARDENE20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1988-12-21e64feba35796…
2022-09-29 23:25 UTC2022-09N019488-002CARDENE30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1988-12-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019488-001CARDENE20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1988-12-21cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019488-002CARDENE30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1988-12-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019488-001CARDENE20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1988-12-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019488-002CARDENE30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1988-12-21a50c72e98297…

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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nicardipine hydrochlorideNICARDIPINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.372a4381-7302-4df7-81bb-a9521907f8672026-08-10Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEMicro Labs Limited8e8611e0-7d8c-4f30-b53a-76c6588b6ef72026-08-04Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEAmerisyn LLC575c5dab-e832-192a-e063-6294a90a34a12026-07-24Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDECaplin Steriles Limited9383f1dc-0310-4c87-a8f0-48c09a85d89b2026-06-25Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine hydrochlorideNICARDIPINE HYDROCHLORIDELifestar Pharma LLCb0e2bed3-f928-43ab-a05c-275bedc9856f2026-04-24Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDESomerset Therapeutics, LLCf8b49f59-7a54-425d-9eca-dfa4022a08d12026-04-20Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
CARDENE IVNICARDIPINE HYDROCHLORIDEBaxter Healthcare Corporationa3e33add-0d09-423a-9109-42e5ba7148d52026-04-13Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
Cardene IVNICARDIPINE HYDROCHLORIDEBaxter Healthcare Corporation5499cfac-9147-4d5d-a8cb-f8d64f1481af2026-04-13Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
CARDENE IVNICARDIPINE HYDROCHLORIDEBaxter Healthcare Corporationf12cea0d-b7cd-41d8-b551-2c74cc7f5f4e2026-03-27Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEFresenius Kabi USA, LLCcdafe6cc-b03e-4e72-9d0a-6baa977149d62026-03-06Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USA3955d43d-a87f-4d2c-b90e-3ecf0d6aa1482026-01-29Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEAmici Pharma Incedda985c-004e-4487-b856-13cf2cdb900f2026-01-08Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
CARDENE IVNICARDIPINE HYDROCHLORIDEBaxter Healthcare Corporation5749599d-ff2a-42e4-aa72-cd25013feee82025-12-29Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDESagent Pharmaceuticalsc576c9d5-853b-4e93-be6c-3579dfa5564c2025-12-29Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEANI Pharmaceuticals, Inc.d1e275b8-c71a-4e8b-bca0-cfea048b53432025-12-22Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEChengdu Shuode Pharmaceutical Co., Ltd433dbca3-0a86-44c2-835d-1051c1c938782025-11-10Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEQilu Pharmaceutical Co., Ltd.7433b5cd-9c3a-428a-bcaf-00f02cd526332025-04-23Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDECipla USA Inc.570af1f8-6718-4b40-ae89-0f738d330ebd2025-04-08Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst9d898911-d811-2a78-e053-2995a90af7842025-01-08Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEArchis Pharma LLCd0070638-bea5-413a-8658-4c752c6104f52024-12-05Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45116SUPPL2016-08-26
45069SUPPL2016-08-26