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Serving leading biopharmaceutical companies globally:

McKesson
Teva
Mallinckrodt
Argus Health
US Army
Johnson and Johnson
Chubb
UBS
Medtronic
Boehringer Ingelheim

Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075853

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NDA 075853 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 forty-three 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-seven suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.

Summary for 075853

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075853

Mechanism of ActionCalcium Channel Antagonists

Suppliers and Packaging for NDA: 075853

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride INJECTABLE;INJECTION 075853 ANDA Hospira, Inc. 0409-4350 0409-4350-03 10 VIAL, PATENT DELIVERY SYSTEM in 1 TRAY (0409-4350-03) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/VIAL
Approval Date:Dec 17, 2002TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Deloitte
Merck
US Department of Justice
Medtronic
Teva
Accenture
QuintilesIMS
Julphar
Cerilliant

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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