Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018792
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEOPHAM 6.4% AMINO ACIDS 6.4% (6.4GM/100ML) 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
01/17/1984 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
02/09/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/11/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/30/1994 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/1990 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/1990 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/11/1986 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/1986 SUPPL-6 Labeling

Label is not available on this site.

07/27/1984 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/19/1985 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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