Drugs@FDA: FDA Approved Drug Products

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

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

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

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