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Generated: December 16, 2017

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-two suppliers are listed for this compound. Additional details are available on the felodipine profile page.

Summary for 019834

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
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)

Summary 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EXTENDED RELEASE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Summary 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EXTENDED RELEASE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Summary 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EXTENDED RELEASE;ORALStrength2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 Orange Book Patents for NDA: 019834

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
AstrazenecaPLENDILfelodipineTABLET, EXTENDED RELEASE;ORAL019834-004Sep 22, 1994► Subscribe► Subscribe
AstrazenecaPLENDILfelodipineTABLET, EXTENDED RELEASE;ORAL019834-002Jul 25, 1991► Subscribe► Subscribe
AstrazenecaPLENDILfelodipineTABLET, EXTENDED RELEASE;ORAL019834-001Jul 25, 1991► Subscribe► Subscribe
AstrazenecaPLENDILfelodipineTABLET, EXTENDED RELEASE;ORAL019834-002Jul 25, 1991► Subscribe► Subscribe
AstrazenecaPLENDILfelodipineTABLET, EXTENDED RELEASE;ORAL019834-001Jul 25, 1991► Subscribe► Subscribe
AstrazenecaPLENDILfelodipineTABLET, EXTENDED RELEASE;ORAL019834-004Sep 22, 1994► Subscribe► Subscribe
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Novartis
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