Application 017854

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REGLAN	METOCLOPRAMIDE HYDROCHLORIDE	TABLET;ORAL	EQ 10MG BASE	Yes	Yes
002	REGLAN	METOCLOPRAMIDE HYDROCHLORIDE	TABLET;ORAL	EQ 5MG BASE	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62559-165	Reglan	Metoclopramide Hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-165	Reglan	Metoclopramide Hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-165	Reglan	Metoclopramide Hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-166	Reglan	Metoclopramide Hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-166	Reglan	Metoclopramide Hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-166	Reglan	Metoclopramide Hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-295	Metoclopramide	Metoclopramide	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-296	Metoclopramide	Metoclopramide	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current