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Generated: May 27, 2017

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Details for New Drug Application (NDA): 075401

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NDA 075401 describes TAZTIA 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 TAZTIA XT profile page.

The generic ingredient in TAZTIA 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 NDA: 075401

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075401

Mechanism of ActionCalcium Channel Antagonists

Suppliers and Packaging for NDA: 075401

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 075401 ANDA American Health Packaging 60687-110 60687-110-32 20 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-110-32) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (60687-110-33)
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 075401 ANDA Actavis Pharma, Inc. 62037-696 62037-696-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (62037-696-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Apr 10, 2003TE:AB4RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Apr 10, 2003TE:AB4RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength240MG
Approval Date:Apr 10, 2003TE:AB4RLD:No

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