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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 074617

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NDA 074617 describes DILTIAZEM HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Actavis Labs Fl Inc, Alembic, Apotex, Biovail, Chartwell Rx, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Mylan, Nesher Pharms, Novast Labs, Ph Health, Pharmobedient, Sun Pharm, Teva, Twi Pharms, Utopic Pharms, Valeant Pharms North, Zydus Pharms, Dr Reddys, Eugia Pharma, Hikma, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, Rising, Sagent, Amta, Sciegen Pharms Inc, Apothecon, Chartwell Molecules, Edenbridge Pharms, Ivax Sub Teva Pharms, Teva Pharms, Zydus Lifesciences, Hq Spclt Pharma, and Exela Pharma, and is included in fifty-six NDAs. It is available from forty-nine 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. Fifty-four suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.

Summary for 074617

Tradename:	DILTIAZEM HYDROCHLORIDE
Applicant:	Sagent
Ingredient:	diltiazem hydrochloride
Patents:	0

Pharmacology for NDA: 074617

Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors

Suppliers and Packaging for NDA: 074617

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	INJECTABLE;INJECTION	074617	ANDA	Sagent Pharmaceuticals	25021-319	25021-319-05	10 VIAL in 1 CARTON (25021-319-05) / 5 mL in 1 VIAL
DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	INJECTABLE;INJECTION	074617	ANDA	Sagent Pharmaceuticals	25021-319	25021-319-10	10 VIAL in 1 CARTON (25021-319-10) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5MG/ML
Approval Date:	Feb 28, 1996	TE:	AP	RLD:	No

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