Details for New Drug Application (NDA): 074752

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. Fifty-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

Pharmacology for NDA: 074752

Mechanism of Action

Calcium 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	Actavis Pharma, Inc.	62037-597	62037-597-05	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62037-597-05)
CARTIA XT	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	074752	ANDA	Actavis Pharma, Inc.	62037-597	62037-597-90	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62037-597-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	180MG
Approval Date:	Jul 9, 1998	TE:	AB3	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	120MG
Approval Date:	Jul 9, 1998	TE:	AB3	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	240MG
Approval Date:	Jul 9, 1998	TE:	AB3	RLD:	No

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