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Last Updated: December 21, 2024

Details for New Drug Application (NDA): 211015

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NDA 211015 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-three 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-six suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.

Summary for 211015

Tradename:	VERAPAMIL HYDROCHLORIDE
Applicant:	Somerset Theraps Llc
Ingredient:	verapamil hydrochloride
Patents:	0

Pharmacology for NDA: 211015

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

Medical Subject Heading (MeSH) Categories for 211015

Anti-Arrhythmia Agents
Calcium Channel Blockers
Vasodilator Agents

Suppliers and Packaging for NDA: 211015

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	SOLUTION;INTRAVENOUS	211015	ANDA	Henry Schein, Inc.	0404-9966	0404-9966-02	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9966-02) / 2 mL in 1 VIAL, SINGLE-DOSE
VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	SOLUTION;INTRAVENOUS	211015	ANDA	Henry Schein, Inc.	0404-9967	0404-9967-04	1 VIAL in 1 BAG (0404-9967-04) / 4 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	5MG/2ML (2.5MG/ML)
Approval Date:	Jun 18, 2018	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	10MG/4ML (2.5MG/ML)
Approval Date:	Jun 18, 2018	TE:	AP	RLD:	No

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