Product Details for NDA 020005
CARDENE SR (NICARDIPINE HYDROCHLORIDE)
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NICARDIPINE HYDROCHLORIDE
Proprietary Name: CARDENE SR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020005
Product Number: 001
Approval Date: Feb 21, 1992
Applicant Holder Full Name: CHIESI USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CARDENE SR (NICARDIPINE HYDROCHLORIDE)
Proprietary Name: CARDENE SR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020005
Product Number: 001
Approval Date: Feb 21, 1992
Applicant Holder Full Name: CHIESI USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NICARDIPINE HYDROCHLORIDE
Proprietary Name: CARDENE SR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020005
Product Number: 002
Approval Date: Feb 21, 1992
Applicant Holder Full Name: CHIESI USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CARDENE SR (NICARDIPINE HYDROCHLORIDE)
Proprietary Name: CARDENE SR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020005
Product Number: 002
Approval Date: Feb 21, 1992
Applicant Holder Full Name: CHIESI USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NICARDIPINE HYDROCHLORIDE
Proprietary Name: CARDENE SR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020005
Product Number: 003
Approval Date: Feb 21, 1992
Applicant Holder Full Name: CHIESI USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: CARDENE SR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020005
Product Number: 003
Approval Date: Feb 21, 1992
Applicant Holder Full Name: CHIESI USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information