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

Serving hundreds of leading biopharmaceutical companies globally:

Citi
Argus Health
Farmers Insurance
Deloitte
Fish and Richardson
Express Scripts
Johnson and Johnson
US Army
QuintilesIMS

Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077317

« Back to Dashboard

NDA 077317 describes ISRADIPINE, which is a drug marketed by Elite Labs Inc, Watson Labs Teva, and Mylan Pharms Inc, and is included in three NDAs. It is available from five suppliers. Additional details are available on the ISRADIPINE profile page.

The generic ingredient in ISRADIPINE is isradipine. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the isradipine profile page.
Summary for 077317
Tradename:ISRADIPINE
Applicant:Watson Labs Teva
Ingredient:isradipine
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077317
Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 077317
Suppliers and Packaging for NDA: 077317
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISRADIPINE isradipine CAPSULE;ORAL 077317 ANDA Actavis Pharma, Inc. 16252-539 N 16252-539-01
ISRADIPINE isradipine CAPSULE;ORAL 077317 ANDA Actavis Pharma, Inc. 16252-540 N 16252-540-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MG
Approval Date:Jan 5, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Jan 5, 2006TE:ABRLD:No

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Baxter
Julphar
Deloitte
US Army
Express Scripts
Federal Trade Commission
Mallinckrodt
Covington

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.