An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

Products on NDA 019887

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019887

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/1989	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/16/2013	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
02/08/2011	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019887s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019887s014ltr.pdf
06/19/1996	SUPPL-7	Labeling		Label is not available on this site.
03/29/1996	SUPPL-6	Labeling		Label is not available on this site.
05/31/1994	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
03/22/1996	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
03/05/1996	SUPPL-2	Efficacy-New Indication		Label is not available on this site.
08/21/1989	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

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

Therapeutic Equivalents for NDA 019887

NEBUPENT

FOR SOLUTION;INHALATION; 300MG/VIAL
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NEBUPENT	PENTAMIDINE ISETHIONATE	300MG/VIAL	FOR SOLUTION;INHALATION	Prescription	Yes	AN	019887	FRESENIUS KABI USA
PENTAMIDINE ISETHIONATE	PENTAMIDINE ISETHIONATE	300MG/VIAL	FOR SOLUTION;INHALATION	Prescription	No	AN	206667	SETON PHARMS
PENTAMIDINE ISETHIONATE	PENTAMIDINE ISETHIONATE	300MG/VIAL	FOR SOLUTION;INHALATION	Prescription	No	AN	206983	X-GEN PHARMS INC

Top