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Moodys
Dow
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Citi
AstraZeneca
Julphar
Fuji
Teva
Cantor Fitzgerald

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091022

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NDA 091022 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 091022
Tradename:DILTIAZEM HYDROCHLORIDE
Applicant:Sandoz
Ingredient:diltiazem hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091022
Mechanism of ActionCalcium Channel Antagonists
Suppliers and Packaging for NDA: 091022
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 091022 ANDA Sandoz Inc 0781-2452 N 0781-2452-05
DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 091022 ANDA Sandoz Inc 0781-2452 N 0781-2452-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Sep 28, 2012TE:AB4RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Sep 28, 2012TE:AB4RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength240MG
Approval Date:Sep 28, 2012TE:AB4RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Julphar
QuintilesIMS
McKinsey
Johnson and Johnson
Harvard Business School
Colorcon
Argus Health
Farmers Insurance

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