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Generated: October 15, 2018

DrugPatentWatch Database Preview

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. It is available from two suppliers. 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. Twenty-one 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 019834
Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 019834
Suppliers and Packaging for NDA: 019834
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PLENDIL felodipine TABLET, EXTENDED RELEASE;ORAL 019834 NDA Ranbaxy Pharmaceuticals Inc 63304-435 63304-435-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-435-01)
PLENDIL felodipine TABLET, EXTENDED RELEASE;ORAL 019834 NDA Ranbaxy Pharmaceuticals Inc 63304-436 63304-436-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-436-01)

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EXTENDED RELEASE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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EXTENDED RELEASE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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EXTENDED RELEASE;ORALStrength2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 019834-002 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 019834-001 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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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
McKinsey
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Boehringer Ingelheim
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Cipla
Cantor Fitzgerald
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Farmers Insurance

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