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McKesson
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Johnson and Johnson
Healthtrust
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Accenture
Julphar
UBS
Boehringer Ingelheim

Generated: May 23, 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-two 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
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 E 63304-435-01
PLENDIL felodipine TABLET, EXTENDED RELEASE;ORAL 019834 NDA Ranbaxy Pharmaceuticals Inc 63304-436 E 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EXTENDED RELEASE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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EXTENDED RELEASE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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EXTENDED RELEASE;ORALStrength2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 019834-001 Jul 25, 1991 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca PLENDIL felodipine TABLET, EXTENDED RELEASE;ORAL 019834-004 Sep 22, 1994 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca PLENDIL felodipine TABLET, EXTENDED RELEASE;ORAL 019834-002 Jul 25, 1991 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca PLENDIL felodipine TABLET, EXTENDED RELEASE;ORAL 019834-002 Jul 25, 1991 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Baxter
Express Scripts
Julphar
US Department of Justice
Queensland Health
Fuji
QuintilesIMS
Fish and Richardson

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