Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 022246

Expand all

METOZOLV ODT (METOCLOPRAMIDE HYDROCHLORIDE)
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: METOCLOPRAMIDE HYDROCHLORIDE
Proprietary Name: METOZOLV ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022246
Product Number: 001
Approval Date: Sep 4, 2009
Applicant Holder Full Name: SALIX PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
METOZOLV ODT (METOCLOPRAMIDE HYDROCHLORIDE)
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: METOCLOPRAMIDE HYDROCHLORIDE
Proprietary Name: METOZOLV ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022246
Product Number: 002
Approval Date: Sep 4, 2009
Applicant Holder Full Name: SALIX PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English