Details for New Drug Application (NDA): 022246

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NDA 022246 describes METOZOLV ODT, which is a drug marketed by Salix Pharms and is included in one NDA. Additional details are available on the METOZOLV ODT profile page.

The generic ingredient in METOZOLV ODT is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

Summary for 022246

Tradename:	METOZOLV ODT
Applicant:	Salix Pharms
Ingredient:	metoclopramide hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 022246

Antiemetics
Dopamine D2 Receptor Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 4, 2009	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 4, 2009	TE:		RLD:	Yes

Expired US Patents for NDA 022246

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix Pharms	METOZOLV ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	022246-001	Sep 4, 2009	⤷ Sign Up	⤷ Sign Up
Salix Pharms	METOZOLV ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	022246-002	Sep 4, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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