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Last Updated: March 25, 2025

Details for New Drug Application (NDA): 216471

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NDA 216471 describes VERAPAMIL HYDROCHLORIDE, which is a drug marketed by Mylan, Rising, Abraxis Pharm, Bedford, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Heritage, Hospira, Intl Medication, Luitpold, Mankind Pharma, Marsam Pharms Llc, Smith And Nephew, Solopak, Zydus Pharms, Amneal, Caplin, Exela Pharma, Micro Labs, Nephron, Somerset, Somerset Theraps Llc, Apotex Corp, Cadila Pharms Ltd, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Pliva, Strides Pharma, Sun Pharm Inds Inc, Actavis Elizabeth, Chartwell Rx, Mutual Pharm, Sun Pharm Industries, Warner Chilcott, and Watson Labs, and is included in sixty-five NDAs. It is available from forty suppliers. Additional details are available on the VERAPAMIL HYDROCHLORIDE profile page.

The generic ingredient in VERAPAMIL HYDROCHLORIDE is verapamil hydrochloride. There are seventeen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.

Summary for 216471

Tradename:	VERAPAMIL HYDROCHLORIDE
Applicant:	Fresenius Kabi Usa
Ingredient:	verapamil hydrochloride
Patents:	0

Pharmacology for NDA: 216471

Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for 216471

Anti-Arrhythmia Agents
Calcium Channel Blockers
Vasodilator Agents

Suppliers and Packaging for NDA: 216471

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	INJECTABLE;INJECTION	216471	ANDA	FRESENIUS KABI USA, LLC	65219-384	65219-384-02	25 VIAL, SINGLE-DOSE in 1 CARTON (65219-384-02) / 2 mL in 1 VIAL, SINGLE-DOSE (65219-384-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2.5MG/ML
Approval Date:	Apr 23, 2024	TE:	AP	RLD:	No

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