Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017698
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STERILE UREA UREA 40GM/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
12/22/1976 ORIG-1 Approval Type 6 - New Indication (no longer used) STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/08/1982 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/11/1982 SUPPL-8 Labeling

Label is not available on this site.

09/03/1980 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/25/1980 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

06/02/1980 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1980 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

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