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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 071881

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NDA 071881 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-five suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.

Summary for 071881

Tradename:	VERAPAMIL HYDROCHLORIDE
Applicant:	Heritage
Ingredient:	verapamil hydrochloride
Patents:	0

Pharmacology for NDA: 071881

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

Medical Subject Heading (MeSH) Categories for 071881

Anti-Arrhythmia Agents
Calcium Channel Blockers
Vasodilator Agents

Suppliers and Packaging for NDA: 071881

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	TABLET;ORAL	071881	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-026	23155-026-01	100 TABLET in 1 BOTTLE (23155-026-01)
VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	TABLET;ORAL	071881	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-026	23155-026-05	500 TABLET in 1 BOTTLE (23155-026-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	120MG
Approval Date:	Apr 5, 1988	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Oct 14, 2015	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Apr 5, 1988	TE:	AB	RLD:	No

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