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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
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Generated: August 18, 2017

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 Hospira, Mylan, Valeant Pharms North, Athenex Inc, Sun Pharma Global, Sandoz, Sun Pharm Inds Ltd, West-ward Pharms Int, Biovail, Apotex, Intl Medication, Hikma Farmaceutica, Apothecon, Actavis Labs Fl Inc, Actavis Elizabeth, Nesher Pharms, Teva Pharms, Ivax Sub Teva Pharms, Mylan Labs Ltd, Teva, Par Pharm, Akorn Inc, Chartwell Molecules, and Teva Pharms Usa, and is included in thirty-four NDAs. It is available from forty-one 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 NDA: 074185

Tradename:
1
Applicant:
1
Ingredient:
1
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 0093-0318-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-0318-01)
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
TABLET;ORAL 074185 ANDA Teva Pharmaceuticals USA, Inc. 0093-0318 0093-0318-05 500 TABLET, FILM COATED in 1 BOTTLE (0093-0318-05)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving 500+ biopharmaceutical companies globally:

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