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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088099
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPARIN SODIUM HEPARIN SODIUM 2,500 UNITS/ML 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
04/28/1983 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
02/14/2001 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

09/09/1998 SUPPL-12 Labeling

Label is not available on this site.

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

Label is not available on this site.

12/02/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/22/1995 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/06/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/07/1992 SUPPL-6 Labeling

Label is not available on this site.

06/01/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/11/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/08/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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