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Generated: November 13, 2018

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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 four 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-five suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 074752
Tradename:CARTIA XT
Applicant:Actavis Labs Fl Inc
Ingredient:diltiazem hydrochloride
Patents:0
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 A-S Medication Solutions 50090-3051 50090-3051-0 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-3051-0)
CARTIA XT diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 074752 ANDA A-S Medication Solutions 50090-3124 50090-3124-0 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-3124-0)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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