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Serving hundreds of leading biopharmaceutical companies globally:

Citi
UBS
Boehringer Ingelheim
Colorcon
Moodys
Covington
Teva
Johnson and Johnson
Mallinckrodt

Generated: July 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074185

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NDA 074185 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-seven NDAs. It is available from forty 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-five suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 074185
Tradename:DILTIAZEM HYDROCHLORIDE
Applicant:Teva
Ingredient:diltiazem hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074185
Mechanism of ActionCalcium Channel Antagonists
Suppliers and Packaging for NDA: 074185
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride TABLET;ORAL 074185 ANDA Teva Pharmaceuticals USA, Inc. 0093-0318 N 0093-0318-01
DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride TABLET;ORAL 074185 ANDA Teva Pharmaceuticals USA, Inc. 0093-0318 N 0093-0318-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:May 31, 1995TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:May 31, 1995TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength90MG
Approval Date:May 31, 1995TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
UBS
Cerilliant
Dow
Argus Health
Moodys
Citi
Baxter
Teva

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