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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074943

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NDA 074943 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-eight suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 074943
Tradename:DILTIAZEM HYDROCHLORIDE
Applicant:Apotex
Ingredient:diltiazem hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074943
Mechanism of ActionCalcium Channel Antagonists
Suppliers and Packaging for NDA: 074943
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 074943 ANDA Apotex Corp. 60505-0014 N 60505-0014-6
DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 074943 ANDA Apotex Corp. 60505-0014 N 60505-0014-8

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength240MG
Approval Date:Aug 6, 1998TE:AB2RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Dec 19, 2000TE:AB2RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Dec 19, 2000TE:AB2RLD:No

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