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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 211596

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NDA 211596 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 211596

Tradename:	DILTIAZEM HYDROCHLORIDE
Applicant:	Edenbridge Pharms
Ingredient:	diltiazem hydrochloride
Patents:	0

Pharmacology for NDA: 211596

Mechanism of Action	Calcium Channel Antagonists

Suppliers and Packaging for NDA: 211596

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	TABLET;ORAL	211596	ANDA	Edenbridge Pharmaceuticals LLC.	42799-129	42799-129-01	100 TABLET, FILM COATED in 1 BOTTLE (42799-129-01)
DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	TABLET;ORAL	211596	ANDA	Edenbridge Pharmaceuticals LLC.	42799-129	42799-129-02	500 TABLET, FILM COATED in 1 BOTTLE (42799-129-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Nov 18, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	60MG
Approval Date:	Nov 18, 2019	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	90MG
Approval Date:	Nov 18, 2019	TE:		RLD:	No

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