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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 216439

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NDA 216439 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 216439

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

Pharmacology for NDA: 216439

Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors

Suppliers and Packaging for NDA: 216439

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216439	ANDA	Slate Run Pharmaceuticals, LLC	70436-195	70436-195-04	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-195-04)
DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216439	ANDA	Slate Run Pharmaceuticals, LLC	70436-195	70436-195-06	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-195-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	120MG
Approval Date:	Mar 7, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	180MG
Approval Date:	Mar 7, 2023	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	240MG
Approval Date:	Mar 7, 2023	TE:	AB	RLD:	No

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