Details for New Drug Application (NDA): 019001

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NDA 019001 describes BEPADIN, which is a drug marketed by Medpointe Pharm Hlc and is included in one NDA. Additional details are available on the BEPADIN profile page.

The generic ingredient in BEPADIN is bepridil hydrochloride. There are four drug master file entries for this compound. Additional details are available on the bepridil hydrochloride profile page.

Summary for 019001

Tradename:	BEPADIN
Applicant:	Medpointe Pharm Hlc
Ingredient:	bepridil hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 019001

Anti-Arrhythmia Agents
Antihypertensive Agents
Calcium Channel Blockers
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Dec 28, 1990	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Dec 28, 1990	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Dec 28, 1990	TE:		RLD:	No

Expired US Patents for NDA 019001

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Medpointe Pharm Hlc	BEPADIN	bepridil hydrochloride	TABLET;ORAL	019001-001	Dec 28, 1990	⤷ Sign Up	⤷ Sign Up
Medpointe Pharm Hlc	BEPADIN	bepridil hydrochloride	TABLET;ORAL	019001-003	Dec 28, 1990	⤷ Sign Up	⤷ Sign Up
Medpointe Pharm Hlc	BEPADIN	bepridil hydrochloride	TABLET;ORAL	019001-002	Dec 28, 1990	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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