.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019834

« Back to Dashboard
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 NDA: 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

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EXTENDED RELEASE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No

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EXTENDED RELEASE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No

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EXTENDED RELEASE;ORALStrength2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No

Expired Orange Book Patents for NDA: 019834

These historical archives are available as an add-on to one-year subscriptions.
See the Subscription Options for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
PLENDIL
felodipine
TABLET, EXTENDED RELEASE;ORAL019834-004Sep 22, 19944,264,611*PED► subscribe
Astrazeneca
PLENDIL
felodipine
TABLET, EXTENDED RELEASE;ORAL019834-001Jul 25, 19914,803,081*PED► subscribe
Astrazeneca
PLENDIL
felodipine
TABLET, EXTENDED RELEASE;ORAL019834-002Jul 25, 19914,803,081*PED► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc