Product Details for NDA 022246
METOZOLV ODT (METOCLOPRAMIDE HYDROCHLORIDE)
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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)
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Strength: EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
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 effectiveness 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