MYLAN SPECIALITY LP Application 020950

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DUONEB	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE	SOLUTION;INHALATION	EQ 0.083% BASE;0.017% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-7322	Ipratropium Bromide and Albuterol Sulfate	ipratropium bromide and albuterol sulfate	Eon Labs, Inc.	NDA	Current