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Details for New Drug Application (NDA): 074067

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NDA 074067 describes DILTIAZEM HYDROCHLORIDE, which is a drug marketed by Hospira, Mylan, Valeant Pharms North, Amphastar Pharms Inc, Sun Pharma Global, Sandoz, Eurohlth Intl Sarl, 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, Dava Pharms Inc, and Teva Pharms Usa, and is included in thirty-three NDAs. It is available from thirty-eight 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-one suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.

Summary for NDA: 074067

Teva Pharms
diltiazem hydrochloride
Therapeutic Class:Cardiovascular Agents

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength30MG
Approval Date:Nov 5, 1992TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength60MG
Approval Date:Nov 5, 1992TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength90MG
Approval Date:Nov 5, 1992TE:RLD:No

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