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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 090529

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NDA 090529 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 090529

Tradename:	VERAPAMIL HYDROCHLORIDE
Applicant:	Sun Pharm Inds Inc
Ingredient:	verapamil hydrochloride
Patents:	0

Pharmacology for NDA: 090529

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

Medical Subject Heading (MeSH) Categories for 090529

Anti-Arrhythmia Agents
Calcium Channel Blockers
Vasodilator Agents

Suppliers and Packaging for NDA: 090529

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090529	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-992	43353-992-60	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-992-60)
VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090529	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-992	43353-992-80	180 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-992-80)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	120MG
Approval Date:	Dec 30, 2011	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	180MG
Approval Date:	Dec 30, 2011	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	240MG
Approval Date:	Dec 30, 2011	TE:		RLD:	No

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