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Abbreviated New Drug Application (ANDA): 206667
Company: SETON PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENTAMIDINE ISETHIONATE PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION;INHALATION Prescription AN 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
04/24/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206667Orig1s000ltr.pdf

PENTAMIDINE ISETHIONATE

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
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