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Generated: November 14, 2018

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Details for New Drug Application (NDA): 020062

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NDA 020062 describes CARDIZEM CD, which is a drug marketed by Valeant Intl and is included in one NDA. It is available from two suppliers. Additional details are available on the CARDIZEM CD profile page.

The generic ingredient in CARDIZEM CD is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 020062
Tradename:CARDIZEM CD
Applicant:Valeant Intl
Ingredient:diltiazem hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020062
Mechanism of ActionCalcium Channel Antagonists
Suppliers and Packaging for NDA: 020062
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062 NDA Valeant Pharmaceuticals North America LLC 0187-0795 0187-0795-30 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0795-30)
CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062 NDA Valeant Pharmaceuticals North America LLC 0187-0795 0187-0795-42 90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0795-42)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Aug 10, 1992TE:AB3RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Dec 27, 1991TE:AB3RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength240MG
Approval Date:Dec 27, 1991TE:AB3RLD:Yes

Expired US Patents for NDA 020062

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062-002 Dec 27, 1991 ➤ Sign Up ➤ Sign Up
Valeant Intl CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062-004 Dec 27, 1991 ➤ Sign Up ➤ Sign Up
Valeant Intl CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062-005 Aug 24, 1999 ➤ Sign Up ➤ Sign Up
Valeant Intl CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062-004 Dec 27, 1991 ➤ Sign Up ➤ Sign Up
Valeant Intl CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062-001 Aug 10, 1992 ➤ Sign Up ➤ Sign Up
Valeant Intl CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062-004 Dec 27, 1991 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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