Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070566
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NITROPRESS SODIUM NITROPRUSSIDE 50MG/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
06/09/1986 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
04/09/2001 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/04/2000 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/30/1994 SUPPL-13 Labeling

Label is not available on this site.

05/10/1995 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/10/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/24/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/30/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/09/1992 SUPPL-8 Labeling

Label is not available on this site.

12/27/1990 SUPPL-7 Labeling

Label is not available on this site.

03/14/1990 SUPPL-6 Labeling

Label is not available on this site.

01/31/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/19/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/19/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/19/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/13/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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