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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021392

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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:1
Applicant:1
Ingredient:1
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 0187-2045-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2045-90)
CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392 NDA Valeant Pharmaceuticals North America LLC 0187-2045 0187-2045-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2045-30)

Summary for product number 001

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

Summary for product number 002

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

Expired Orange Book Patents for NDA: 021392

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant IntlCARDIZEM LAdiltiazem hydrochlorideTABLET, EXTENDED RELEASE;ORAL021392-005Feb 6, 2003► Subscribe► Subscribe
Valeant IntlCARDIZEM LAdiltiazem hydrochlorideTABLET, EXTENDED RELEASE;ORAL021392-006Feb 6, 2003► Subscribe► Subscribe
Valeant IntlCARDIZEM LAdiltiazem hydrochlorideTABLET, EXTENDED RELEASE;ORAL021392-001Feb 6, 2003► Subscribe► Subscribe
Valeant IntlCARDIZEM LAdiltiazem hydrochlorideTABLET, EXTENDED RELEASE;ORAL021392-005Feb 6, 2003► Subscribe► Subscribe
Valeant IntlCARDIZEM LAdiltiazem hydrochlorideTABLET, EXTENDED RELEASE;ORAL021392-004Feb 6, 2003► Subscribe► Subscribe
Valeant IntlCARDIZEM LAdiltiazem hydrochlorideTABLET, EXTENDED RELEASE;ORAL021392-003Feb 6, 2003► Subscribe► Subscribe
Valeant IntlCARDIZEM LAdiltiazem hydrochlorideTABLET, EXTENDED RELEASE;ORAL021392-002Feb 6, 2003► Subscribe► Subscribe
Valeant IntlCARDIZEM LAdiltiazem hydrochlorideTABLET, EXTENDED RELEASE;ORAL021392-003Feb 6, 2003► Subscribe► Subscribe
Valeant IntlCARDIZEM LAdiltiazem hydrochlorideTABLET, EXTENDED RELEASE;ORAL021392-002Feb 6, 2003► Subscribe► Subscribe
Valeant IntlCARDIZEM LAdiltiazem hydrochlorideTABLET, EXTENDED RELEASE;ORAL021392-006Feb 6, 2003► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Harvard Business School
Dow
US Department of Justice
Moodys
Medtronic
Julphar
AstraZeneca
Teva
Federal Trade Commission
Johnson and Johnson

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.

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