U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019264
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENTAM PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/16/1984 ORIG-1 Approval Type 1 - New Molecular Entity 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
01/08/2014 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

02/16/2013 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

05/24/2002 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/24/1997 SUPPL-21 Labeling

Label is not available on this site.

02/26/1997 SUPPL-19 Labeling

Label is not available on this site.

03/18/1996 SUPPL-18 Labeling

Label is not available on this site.

06/08/1994 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1994 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1996 SUPPL-15 Labeling

Label is not available on this site.

08/16/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/09/1993 SUPPL-13 Labeling

Label is not available on this site.

11/14/1988 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/12/1987 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/24/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/24/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/09/1987 SUPPL-4 Labeling

Label is not available on this site.

06/10/1987 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1985 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

PENTAM

INJECTABLE;INJECTION; 300MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PENTAM PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE;INJECTION Prescription Yes AP 019264 FRESENIUS KABI USA
PENTAMIDINE ISETHIONATE PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE;INJECTION Prescription No AP 213806 EMCURE PHARMS LTD
PENTAMIDINE ISETHIONATE PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE;INJECTION Prescription No AP 206666 SETON PHARMS
PENTAMIDINE ISETHIONATE PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE;INJECTION Prescription No AP 206982 XGEN PHARMS
Back to Top