Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089522
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Prescription None No 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
05/04/1987 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/06/2013 SUPPL-47 Labeling-Container/Carton Labels

Label is not available on this site.

11/23/2012 SUPPL-44 Labeling-Package Insert

Label is not available on this site.

05/29/2014 SUPPL-43 Labeling

Label is not available on this site.

01/14/2010 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

01/19/2010 SUPPL-35 Labeling

Label is not available on this site.

05/08/2009 SUPPL-33 Labeling

Label is not available on this site.

10/28/2008 SUPPL-30 Labeling

Label is not available on this site.

02/14/2001 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

09/09/1998 SUPPL-14 Labeling

Label is not available on this site.

08/10/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/11/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/02/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/22/1995 SUPPL-10 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

09/09/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/22/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/22/1993 SUPPL-7 Labeling

Label is not available on this site.

04/06/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/21/1992 SUPPL-4 Labeling

Label is not available on this site.

02/22/1991 SUPPL-3 Labeling

Label is not available on this site.

03/14/1990 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/06/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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