Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020122
Company: HOSPIRA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIPENT PENTOSTATIN 10MG/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
10/11/1991 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
12/29/2015 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/20/2013 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/22/2009 SUPPL-10 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

05/23/2002 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/02/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/08/1998 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/24/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/19/1994 SUPPL-2 Labeling

Label is not available on this site.

09/29/1993 SUPPL-1 Efficacy-New Indication

Label is not available on this site.

NIPENT

INJECTABLE;INJECTION; 10MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIPENT PENTOSTATIN 10MG/VIAL INJECTABLE;INJECTION Prescription Yes AP 020122 HOSPIRA INC
PENTOSTATIN PENTOSTATIN 10MG/VIAL INJECTABLE;INJECTION Prescription No AP 077841 WEST-WARD PHARMS INT

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