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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 four 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-one suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.

Summary for NDA: 020062

Tradename:
CARDIZEM CD
Applicant:
Valeant Intl
Ingredient:
diltiazem hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Aug 10, 1992TE:AB3RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Dec 27, 1991TE:AB3RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength240MG
Approval Date:Dec 27, 1991TE:AB3RLD:No

Expired Orange Book 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;ORAL020062-004Dec 27, 19915,364,620► subscribe
Valeant Intl
CARDIZEM CD
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020062-005Aug 24, 19995,470,584► subscribe
Valeant Intl
CARDIZEM CD
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020062-002Dec 27, 19915,439,689► subscribe
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