Application 022368

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARIDOL KIT	MANNITOL	POWDER;INHALATION	N/A,5MG,10MG,20MG,40MG	Yes	Yes
002	ARIDOL	MANNITOL	POWDER; INHALATION	10MG	Yes	No
003	ARIDOL	MANNITOL	POWDER; INHALATION	20MG	Yes	No
004	ARIDOL	MANNITOL	POWDER; INHALATION	40MG	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67850-552	Aridol Bronchial Challenge Test Kit	mannitol	Methapharm, Inc.	NDA	Current
67850-552	Aridol Bronchial Challenge Test Kit	mannitol	Methapharm, Inc.	NDA	Current
67850-552	Aridol Bronchial Challenge Test Kit	mannitol	Methapharm, Inc.	NDA	Current
67850-552	Aridol Bronchial Challenge Test Kit	mannitol	Methapharm, Inc.	NDA	Current