Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019887
Company: FRESENIUS KABI USA

Products on NDA 19887

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEBUPENT	PENTAMIDINE ISETHIONATE	300MG/VIAL	FOR SOLUTION;INHALATION	Prescription	AN	Yes	Yes
NEBUPENT	PENTAMIDINE ISETHIONATE	600MG/VIAL	FOR SOLUTION;INHALATION	Discontinued	None	No	No

Labels for NDA 019887

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/08/2011	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019887s014lbl.pdf