Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

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

Serving leading biopharmaceutical companies globally:

Fish and Richardson
Daiichi Sankyo
Johnson and Johnson

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077169

« Back to Dashboard

NDA 077169 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 077169
Applicant:Elite Labs Inc
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077169
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 077169
Suppliers and Packaging for NDA: 077169
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISRADIPINE isradipine CAPSULE;ORAL 077169 ANDA Epic Pharma, LLC 42806-263 42806-263-01 100 CAPSULE in 1 BOTTLE (42806-263-01)
ISRADIPINE isradipine CAPSULE;ORAL 077169 ANDA Epic Pharma, LLC 42806-263 42806-263-05 500 CAPSULE in 1 BOTTLE (42806-263-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MG
Approval Date:Apr 24, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Apr 24, 2006TE:ABRLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

US Army
Fish and Richardson
Boehringer Ingelheim

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.