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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Colorcon
Dow
Merck
Harvard Business School
Teva
Fish and Richardson
Healthtrust
Cantor Fitzgerald

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075124

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NDA 075124 describes DILTIAZEM HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Apotex, Biovail, Mylan, Nesher Pharms, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Sun Pharma Global, Teva, Valeant Pharms North, Zydus Pharms Usa Inc, Akorn Inc, Athenex Inc, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, Teva Pharms Usa, West-ward Pharms Int, Apothecon, Chartwell Molecules, Ivax Sub Teva Pharms, and Teva Pharms, and is included in thirty-six NDAs. It is available from thirty-nine suppliers. Additional details are available on the DILTIAZEM HYDROCHLORIDE profile page.

The generic ingredient in DILTIAZEM HYDROCHLORIDE is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 075124
Tradename:DILTIAZEM HYDROCHLORIDE
Applicant:Mylan
Ingredient:diltiazem hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075124
Mechanism of ActionCalcium Channel Antagonists
Suppliers and Packaging for NDA: 075124
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 075124 ANDA Mylan Pharmaceuticals Inc. 0378-5220 N 0378-5220-05
DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 075124 ANDA Mylan Pharmaceuticals Inc. 0378-5220 N 0378-5220-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength240MG
Approval Date:Mar 18, 1998TE:AB2RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Mar 18, 1998TE:AB2RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Mar 18, 1998TE:AB2RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Julphar
McKinsey
Citi
Dow
Daiichi Sankyo
McKesson
Johnson and Johnson
Chinese Patent Office

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