Manufacturing Establishments3
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Chongqing Daxin Pharmaceutical Co. Ltd.
Pari Respiratory Equipment, Inc.
421297606
Woodstock Sterile Solutions, Inc.
Pari Respiratory Equipment, Inc.
117895702
Catalent Pharma Solutions
Pari Respiratory Equipment, Inc.
014167995
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Kitabis Pak
Product Details
NDC Product Code
24492-850Application Number
NDA205433Marketing Category
NDA (C73594)Route of Administration
RESPIRATORY (INHALATION)Effective Date
November 30, 2019TobramycinActive
Code: VZ8RRZ51VKClass: ACTIBQuantity: 300 mg in 5 mL
Sulfuric AcidInactive
Code: O40UQP6WCFClass: IACT
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT