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Details for New Drug Application (NDA): 020005

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NDA 020005 describes CARDENE SR, which is a drug marketed by Chiesi Usa Inc and is included in one NDA. Additional details are available on the CARDENE SR profile page.

The generic ingredient in CARDENE SR is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.

Summary for NDA: 020005

Tradename:
CARDENE SR
Applicant:
Chiesi Usa Inc
Ingredient:
nicardipine hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020005

Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Feb 21, 1992TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength45MG
Approval Date:Feb 21, 1992TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Feb 21, 1992TE:RLD:No

Expired Orange Book Patents for NDA: 020005

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chiesi Usa Inc
CARDENE SR
nicardipine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020005-001Feb 21, 19923,985,758► subscribe
Chiesi Usa Inc
CARDENE SR
nicardipine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020005-002Feb 21, 19925,198,226► subscribe
Chiesi Usa Inc
CARDENE SR
nicardipine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020005-003Feb 21, 19925,198,226► subscribe
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