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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Medtronic
Deloitte
Accenture
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Chubb
Citi
Mallinckrodt
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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075086

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NDA 075086 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 075086

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

Pharmacology for NDA: 075086

Mechanism of ActionCalcium Channel Antagonists

Suppliers and Packaging for NDA: 075086

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride INJECTABLE;INJECTION 075086 ANDA Akorn, Inc. 17478-817 17478-817-26 10 VIAL, SINGLE-USE in 1 CARTON (17478-817-26) > 25 mL in 1 VIAL, SINGLE-USE
DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride INJECTABLE;INJECTION 075086 ANDA Akorn, Inc. 17478-817 17478-817-10 10 VIAL, SINGLE-USE in 1 CARTON (17478-817-10) > 10 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/ML
Approval Date:Apr 9, 1998TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
McKinsey
US Army
Dow
Boehringer Ingelheim
Medtronic
Mallinckrodt
Deloitte
Cerilliant
Julphar

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