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Generated: January 19, 2018

DrugPatentWatch Database Preview

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-seven suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 075401
Tradename:TAZTIA XT
Applicant:Actavis Labs Fl Inc
Ingredient:diltiazem hydrochloride
Patents:0
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
TAZTIA XT diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 075401 ANDA PuraCap Laboratories LLC dba Blu Pharmaceuticals 24658-341 24658-341-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24658-341-30)
TAZTIA XT diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 075401 ANDA PuraCap Laboratories LLC dba Blu Pharmaceuticals 24658-341 24658-341-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24658-341-90)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Medtronic
Julphar
McKinsey
Accenture
Novartis
Express Scripts
Queensland Health
Colorcon

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