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

Serving hundreds of leading biopharmaceutical companies globally:

Covington
Merck
McKesson
AstraZeneca
Fish and Richardson
Cipla
McKinsey
Teva
Cerilliant

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021392

« Back to Dashboard

NDA 021392 describes CARDIZEM LA, which is a drug marketed by Valeant Intl and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the CARDIZEM LA profile page.

The generic ingredient in CARDIZEM LA is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 021392
Tradename:CARDIZEM LA
Applicant:Valeant Intl
Ingredient:diltiazem hydrochloride
Patents:2
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021392
Mechanism of ActionCalcium Channel Antagonists
Suppliers and Packaging for NDA: 021392
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392 NDA Valeant Pharmaceuticals North America LLC 0187-2045 N 0187-2045-30
CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392 NDA Valeant Pharmaceuticals North America LLC 0187-2045 N 0187-2045-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Feb 6, 2003TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Feb 25, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Dec 17, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERTENSION AND ANGINA PECTORIS

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Feb 6, 2003TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Feb 25, 2021Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021392

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-001 Feb 6, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Intl CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-005 Feb 6, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Intl CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-002 Feb 6, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Intl CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-004 Feb 6, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Julphar
Fuji
Fish and Richardson
UBS
Healthtrust
Mallinckrodt
Teva
McKinsey

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.