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Serving leading biopharmaceutical companies globally:

US Department of Justice
Cantor Fitzgerald
Chinese Patent Office

Generated: November 23, 2017

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Details for New Drug Application (NDA): 074943

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NDA 074943 describes DILTIAZEM HYDROCHLORIDE, which is a drug marketed by Hospira, Mylan, Valeant Pharms North, Athenex Inc, Sun Pharma Global, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa Inc, 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-six NDAs. It is available from forty-four 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

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
CAPSULE, EXTENDED RELEASE;ORAL 074943 ANDA Apotex Corp. 60505-0014 60505-0014-6 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-0014-6)
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 074943 ANDA Apotex Corp. 60505-0014 60505-0014-8 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-0014-8)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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Serving leading biopharmaceutical companies globally:

Argus Health
US Army
Harvard Business School
US Department of Justice

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