Orange Book product · Brand (NDA)
METOZOLV ODT
METOCLOPRAMIDE HYDROCHLORIDE
At a glance
Sep 04, 2009
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 04, 2009
17 yr ago
Today
Pharmaceutical detail
Active ingredient
METOCLOPRAMIDE HYDROCHLORIDE
Strength
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
TE code
Not listed
Application
NDA 022246
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2020GIMOTIBrand (NDA)
NDA 209388 · QOL MEDCL
- 2005REGLAN ODTBrand (NDA)
NDA 021793 · MEDA PHARMS
- 1983REGLANBrand (NDA)
NDA 018821 · ROBINS AH
- —REGLANBrand (NDA)
NDA 017862 · HIKMA
- 2024METOCLOPRAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 072215 · AIPING PHARM INC
- 2014METOCLOPRAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 202191 · NOVEL LABS INC
- 2013METOCLOPRAMIDEGeneric (ANDA)
ANDA 204756 · AVET LIFESCIENCES
- 2013METOCLOPRAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 091392 · FRESENIUS KABI USA
- 2008METOCLOPRAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 078807 · IPCA LABS LTD
- 2007METOCLOPRAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 078374 · NORTHSTAR HLTHCARE
- 2001METOCLOPRAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 075051 · VISTAPHARM LLC
- 1997METOCLOPRAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 074703 · PHARMOBEDIENT CNSLTG
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
