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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Chubb
Harvard Business School
Daiichi Sankyo
Cipla
Boehringer Ingelheim
Colorcon
Federal Trade Commission
Queensland Health

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090492

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NDA 090492 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-two 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 090492
Tradename:DILTIAZEM HYDROCHLORIDE
Applicant:Sun Pharma Global
Ingredient:diltiazem hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090492
Mechanism of ActionCalcium Channel Antagonists
Suppliers and Packaging for NDA: 090492
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 090492 ANDA Sun Pharma Global FZE 47335-675 N 47335-675-13
DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 090492 ANDA Sun Pharma Global FZE 47335-675 N 47335-675-18

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Oct 28, 2011TE:AB3RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Oct 28, 2011TE:AB3RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength240MG
Approval Date:Oct 28, 2011TE:AB3RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
UBS
Mallinckrodt
Deloitte
AstraZeneca
Medtronic
Express Scripts
QuintilesIMS
Fish and Richardson

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