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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 019834


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NDA 019834 describes PLENDIL, which is a drug marketed by Astrazeneca and is included in one NDA. Additional details are available on the PLENDIL profile page.

The generic ingredient in PLENDIL is felodipine. There are seventeen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the felodipine profile page.
Summary for 019834
Tradename:PLENDIL
Applicant:Astrazeneca
Ingredient:felodipine
Patents:0
Medical Subject Heading (MeSH) Categories for 019834

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jul 25, 1991TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jul 25, 1991TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Sep 22, 1994TE:RLD:Yes

Expired US Patents for NDA 019834

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca PLENDIL felodipine TABLET, EXTENDED RELEASE;ORAL 019834-001 Jul 25, 1991 ⤷  Sign Up ⤷  Sign Up
Astrazeneca PLENDIL felodipine TABLET, EXTENDED RELEASE;ORAL 019834-004 Sep 22, 1994 ⤷  Sign Up ⤷  Sign Up
Astrazeneca PLENDIL felodipine TABLET, EXTENDED RELEASE;ORAL 019834-002 Jul 25, 1991 ⤷  Sign Up ⤷  Sign Up
Astrazeneca PLENDIL felodipine TABLET, EXTENDED RELEASE;ORAL 019834-001 Jul 25, 1991 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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