NOVITIUM PHARMA Application 215003

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	SUSPENSION;ORAL	EQ 10MG BASE/5ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70954-319	Paroxetine	Paroxetine	Novitium Pharma LLC	ANDA	Current
70954-319	Paroxetine	Paroxetine	Novitium Pharma LLC	ANDA	Current
70954-319	Paroxetine	Paroxetine	ANI Pharmaceuticals, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
68924	ORIG	2021-10-08