Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073479
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENTAMIDINE ISETHIONATE PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE;INJECTION 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
06/30/1992 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/073479_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/12/2002 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

04/10/2002 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

05/27/1999 SUPPL-8 Labeling

Label is not available on this site.

12/09/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/20/1996 SUPPL-4 Labeling

Label is not available on this site.

06/12/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/15/1993 SUPPL-2 Labeling

Label is not available on this site.

06/01/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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