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Details for New Drug Application (NDA): 074752

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NDA 074752 describes CARTIA XT, which is a drug marketed by Actavis Labs Fl Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the CARTIA XT profile page.

The generic ingredient in CARTIA XT 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: 074752

Tradename:
CARTIA XT
Applicant:
Actavis Labs Fl Inc
Ingredient:
diltiazem hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 074752

Mechanism of ActionCalcium Channel Antagonists

Suppliers and Packaging for NDA: 074752

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARTIA XT
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 074752 ANDA REMEDYREPACK INC. 61786-915 61786-915-02 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (61786-915-02)
CARTIA XT
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 074752 ANDA Actavis Pharma, Inc. 62037-597 62037-597-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62037-597-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Jul 9, 1998TE:AB3RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Jul 9, 1998TE:AB3RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength240MG
Approval Date:Jul 9, 1998TE:AB3RLD:No


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