Product Details for NDA 019834
PLENDIL (FELODIPINE)
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FELODIPINE
Proprietary Name: PLENDIL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019834
Product Number: 004
Approval Date: Sep 22, 1994
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Discontinued
Patent and Exclusivity Information
PLENDIL (FELODIPINE)
Proprietary Name: PLENDIL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019834
Product Number: 004
Approval Date: Sep 22, 1994
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Discontinued
Patent and Exclusivity Information
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FELODIPINE
Proprietary Name: PLENDIL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019834
Product Number: 001
Approval Date: Jul 25, 1991
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Discontinued
Patent and Exclusivity Information
PLENDIL (FELODIPINE)
Proprietary Name: PLENDIL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG **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: N019834
Product Number: 001
Approval Date: Jul 25, 1991
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FELODIPINE
Proprietary Name: PLENDIL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG **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: N019834
Product Number: 002
Approval Date: Jul 25, 1991
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PLENDIL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG **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: N019834
Product Number: 002
Approval Date: Jul 25, 1991
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Discontinued
Patent and Exclusivity Information