Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012154
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
UREAPHIL 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
10/05/1966 ORIG-1 Approval Type 3 - New Dosage Form 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
04/03/2002 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/03/2002 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/06/2000 SUPPL-24 Labeling

Label is not available on this site.

12/16/2002 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12154slr023ltr.pdf
10/28/1985 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1981 SUPPL-21 Labeling

Label is not available on this site.

04/28/1982 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1982 SUPPL-19 Labeling

Label is not available on this site.

06/24/1980 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1980 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

02/29/1980 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

10/11/1978 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1977 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

09/02/1977 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1976 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

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