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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 076563

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NDA 076563 describes DILTIAZEM HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Actavis Labs Fl Inc, Apotex, Biovail, Dr Reddys Labs Sa, Endo Operations, Glenmark Pharms Ltd, Mylan, Nesher Pharms, Norvium Bioscience, Novast Labs, Sandoz, 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, and Exela Pharma, and is included in fifty NDAs. It is available from forty-six 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-three suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.

Summary for 076563

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	420MG
Approval Date:	Sep 12, 2006	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	120MG
Approval Date:	Sep 12, 2006	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	180MG
Approval Date:	Sep 12, 2006	TE:		RLD:	No

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