PAR PHARM INC Application 210027

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	POWDER;ORAL	500MG/PACKET	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-873	SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	Par Pharmaceutical, Inc.	ANDA	Current
49884-873	SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	Par Pharmaceutical, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
60140	ORIG	2019-09-27